Biotestcell® 1 & 2 816014100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07611969952380), received between Dec 21, 2016 and Sep 12, 2024 — classified as 29 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCONSISTENT, RESPECTIVELY DISCREPANT SCREENING RESULTS USING BIOTESTCELL-I11 PLUS (THIS REPORT), BIOTESTCELL 1,2 (REPORT 9610824-2024-00037), AND BIOTESTCELL-I 11 (REPORT 9610824-2024-00038) ON THEIR TANGO INFINITY INSTRUMENT. PREVIOUSLY TESTED PATIENT SAMPLES THAT RETURNED POSITIVE REACTIONS WERE RE-DRAWN AND THE SECOND SAMPLES SHOWED NEGATIVE RESULTS, SO THE CUSTOMER SUSPECTED FALSE POSITIVE RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. AT FIRST, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE BIOTESTCELL-I11 PLUS WITH 4 KNOWN ANTIBODIES (ANTI-C, ANTI-FYA, ANTI-K (DETERMINED IN DOUBLE), AND SOLIDSCREEN II CONTROL). ALSO TESTED WERE THREE DONOR SAMPLES SUPPOSED TO BE ANTIBODY FREE. SOLIDSCREEN II NEGATIVE CONTROL WAS ALSO USED IN THIS TESTING. ALL TEST RESULTS WERE WITHIN EXPECTATIONS. THE TESTS CARRIED OUT IN DOUBLE DETERMINATION ACHIEVED THE SAME TEST RESULTS (+/- 1 REACTION STRENGTH) WHEN TESTING THE POSITIVE ANTIBODIES. THE DONOR SAMPLES AS WELL AS THE SOLIDSCREEN II NEGATIVE CONTROL REACTED NEGATIVELY. THE POSITIVE CONTROL SOLIDSCREEN II CONTROL (ANTI-D) REACTED CLEARLY POSITIVE. A REVIEW OF THE BATCH RECORD DOCUMENTATION S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198247 ↗
• MalfunctionSep 12, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCONSISTENT, RESPECTIVELY DISCREPANT SCREENING RESULTS USING BIOTESTCELL-I11 (THIS REPORT), BIOTESTCELL 1,2 (REPORT 9610824-2024-00037), AND BIOTESTCELL-I 11 PLUS (REPORT 9610824-2024-00039) ON THEIR TANGO INFINITY INSTRUMENT. PREVIOUSLY TESTED PATIENT SAMPLES THAT RETURNED POSITIVE REACTIONS WERE RE-DRAWN AND THE SECOND SAMPLES ARE SHOWING NEGATIVE RESULTS, SO THE CUSTOMER SUSPECTED FALSE POSITIVE RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. AT FIRST, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE BIOTESTCELL-I11 WITH 4 KNOWN ANTIBODIES (ANTI-C, ANTI-FYA, ANTI-K (DETERMINED IN DOUBLE), AND SOLIDSCREEN II CONTROL), ALSO TESTED WERE THREE DONOR SAMPLES SUPPOSED TO BE ANTIBODY FREE. SOLIDSCREEN II NEGATIVE CONTROL WAS ALSO USED IN THIS TESTING. ALL TEST RESULTS WERE WITHIN EXPECTATIONS. THE TESTS CARRIED OUT IN DOUBLE DETERMINATION ACHIEVED THE SAME TEST RESULTS (+/- 1 REACTION STRENGTH) WHEN TESTING THE POSITIVE ANTIBODIES. THE DONOR SAMPLES AS WELL AS THE SOLIDSCREEN II NEGATIVE CONTROL REACTED NEGATIVELY. THE POSITIVE CONTROL SOLIDSCREEN II CONTROL (ANTI-D) REACTED CLEARLY POSITIVE WITH D-POS.REAGENT RED BLOOD CELLS. A REVIEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198246 ↗
• MalfunctionSep 12, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCONSISTENT, RESPECTIVELY DISCREPANT SCREENING RESULTS USING BIOTESTCELL 1,2 (THIS REPORT), BIOTESTCELL-I 11 (REPORT 9610824-2024-00038), AND BIOTESTCELL-I 11 PLUS (REPORT 9610824-2024-00039) ON THEIR TANGO INFINITY INSTRUMENT. PREVIOUSLY TESTED PATIENT SAMPLES THAT RETURNED POSITIVE REACTIONS WERE RE-DRAWN AND THE SECOND SAMPLES ARE SHOWING NEGATIVE RESULTS, SO THE CUSTOMER SUSPECTED FALSE POSITIVE RESULTS. THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. AT FIRST, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE BIOTESTCELL 1,2 WITH 5 KNOWN ANTIBODIES (ANTI-C, ANTI-FYA, ANTI-K, SOLID SCREEN II CONTROL AND SOLID SCREEN II CONTROL B), DETERMINED IN DOUBLE AND 3 DONOR SAMPLES SUPPOSED TO BE ANTIBODY FREE. SOLID SCREEN II NEGATIVE CONTROL WAS ALSO USED IN THIS TESTING. THE TESTS CARRIED OUT IN DOUBLE DETERMINATION WERE CONCLUSIVE, THE TEST RESULTS ALWAYS MATCHED. THE DONOR SAMPLES AS WELL AS THE SOLID SCREEN II NEGATIVE CONTROL REACTED NEGATIVELY. ALL RESULTS WERE WITHIN EXPECTATIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.- THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198245 ↗
• MalfunctionJul 25, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED INCONSISTENT RESULTS OF A CAP SURVEY SAMPLE WITH BIOTESTCELL 1&2 ON THE TANGO INFINITY. THE CUSTOMER TESTED THE CAP SURVEY SAMPLE SEVERAL TIMES ON TANGO INFINITY AND IN MOST CASES THE REACTIONS WERE POSITIVE WITH CELL #1 OF BIOTESTCELL 1&2 BUT IN TWO CASES THEY WERE NEGATIVE. THE CUSTOMER STATED THAT THEY ALSO TESTED THE CAP SURVEY SAMPLE WITH BIOTESTCELL 1&2 IN THE TUBE METHOD AND RECEIVED A POSITIVE RESULT. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE CAP SURVEY SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON TANGO INFINITY. THE TESTS WERE PERFORMED USING POSITIVE AND NEGATIVE CONTROL, DIFFERENT DONOR SAMPLES AND TWO KNOWN ANTIBODIES (ANTI-K AND ANTI-M) FROM INTERLABORATORY COMPARISON TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE TWO KNOWN ANTIBODIES WERE PROCESSED THREE TIMES ON THE TANGO INFINITY. THEY SHOWED THE SAME CORRECT RESULT IN EACH RUN. WE DID NOT OBSERVE ANY FALSE NEGATIVE OR INCONSISTENT RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386650 ↗
• MalfunctionJul 24, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED INCONSISTENT RESULTS OF A CAP SURVEY SAMPLE WITH BIOTESTCELL 1&2 ON THE TANGO INFINITY. THE CUSTOMER TESTED THE CAP SURVEY SAMPLE SEVERAL TIMES ON THE TANGO INFINITY AND IN MOST CASES THE REACTIONS WERE POSITIVE WITH CELL #1 OF BIOTESTCELL 1&2 BUT IN TWO CASES THEY WERE NEGATIVE. THE CUSTOMER STATED THAT THEY ALSO TESTED THE CAP SURVEY SAMPLE WITH BIOTESTCELL 1&2 IN THE TUBE METHOD AND RECEIVED A POSITIVE RESULT. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE CAP SURVEY SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON TANGO INFINITY. THE TESTS WERE PERFORMED USING POSITIVE AND NEGATIVE CONTROL, DIFFERENT DONOR SAMPLES AND TWO KNOWN ANTIBODIES (ANTI-K AND ANTI-M) FROM INTERLABORATORY COMPARISON TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE TWO KNOWN ANTIBODIES WERE PROCESSED THREE TIMES ON THE TANGO INFINITY. THEY SHOWED THE SAME CORRECT RESULT IN EACH RUN. WE DID NOT OBSERVE ANY FALSE NEGATIVE OR INCONSISTENT RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376987 ↗
• MalfunctionOct 11, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE SHOWED A POSITIVE ANTIBODY SCREENING TEST WITH BIOTESTCELL 1&2 ON TANGO INFINITY. ON FURTHER INVESTIGATION THE CUSTOMER WAS ABLE TO IDENTIFY AN ANTI-CW. THEY USED BIOTESTCELL-I11 PLUS AND PANEL CELLS FROM IMMUCOR FOR THE ANTIBODY IDENTIFICATION. THE CUSTOMER WAS CONCERNED BECAUSE BOTH CELLS OF THE AFFECTED BIOTESTCELL 1&2 LOT WERE CW NEGATIVE ACCORDING TO THE PROVIDED ANTIGEN TABLE. BASED ON THEIR TEST RESULTS THE CUSTOMER SUSPECTED A TYPING ERROR IN THE ANTIGEN TABLE OR A MISTYPING OF THE AFFECTED LOT BIOTESTCELL 1&2. THE CUSTOMER DID NOT RETURN THE AFFECTED PRODUCT BIOTESTCELL 1&2 OR THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. BOTH AFFECTED SCREENING CELLS WERE TESTED WITH SERACLONE ANTI-CW. BOTH SHOWED NEGATIVE RESULTS. ADDITIONALLY, THE RETENTION SAMPLE OF BIOTESTCELL 1&2 WAS TESTED WITH AN ANTI-CW (IGG TYPE) ON TANGO INFINITY. AGAIN, BOTH SCREENING CELLS SHOWED COMPLETELY NEGATIVE RESULTS. THE ANTIGENS OF BOTH DONORS HAD BEEN TESTED, AMONG OTHERS THE CW ANTIGEN IN THE DOUBLE DETERMINATION. BOTH DONORS SHOWED NEGATIVE RESULTS. W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605635 ↗
• MalfunctionNov 26, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT BIOTEST CELL 1&2 (REF #816014100, LOT #8039011-00) FAILED WITH ALBAQ-CHEK QC VIAL #1. THE CUSTOMER STATED THAT SHE PERFORMED THE TEST MANUALLY AND INCUBATED FOR 10 MINUTES. THE CUSTOMER USED PEG (POLYETHYLENE-GLYCOL) AS AN ENHANCEMENT MEDIUM. THE VIAL #1 OF ALBAQ-CHEK QC CONTAINED AN ANTI-D, AND WAS SUPPOSED TO YIELD A POSITIVE RESULT WITH BOTH CELLS OF BIOTEST CELL 1&2. BECAUSE THE CUSTOMER DID NOT RETURN ANY REAGENTS FOR INVESTIGATIONAL TESTING OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. BOTH CELLS WERE TESTED WITH DIFFERENT ANTI-D REAGENTS IN THE TUBE TEST. THE TESTING INCLUDED THE FOLLOWING CONDITIONS: IMMEDIATE SPIN, INCUBATION FOR 5 MINUTES AND 15 MINUTES AT ROOM TEMPERATURE AND INDIRECT ANTIGLOBULIN TEST (IAT, 15 MINUTES AT 37°C). ALL ACCEPTANCE CRITERIA WERE MET. THE D ANTIGENS OF BOTH CELLS WERE NOT WEAKENED. ALTHOUGH A CERTAIN VARIATION OF THE D ANTIGEN WITHIN THE SPECIFICATIONS COULD ALWAYS OCCUR, BECAUSE OF THE BIOLOGICAL ORIGIN OF THE REAGENT RED BLOOD CELLS LIKE BIOTEST CELL 1&2. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION AND THE RETENTION SAMPLE REACTED AS EXPECTED. A REVIEW OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911460 ↗
• MalfunctionNov 26, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE SCREENING CELLS BIOTESTCELL P1, P2 AND THEIR PANEL CELLS. THE CUSTOMER STATED THAT A PATIENT APPEARED TO HAVE AN ANTI-LU(A), BUT SHOWED A POSITIVE REACTION WITH CELL #1 OF BIOTESTCELL WHICH IS LU(A) NEGATIVE ACCORDING TO THE ANTIGEN TABLE. FURTHERMORE THE CUSTOMER STATED THAT THE PATIENT SAMPLE YIELDED A NEGATIVE SCREENING RESULT ON TANGO INFINITY. SHE DID NOT PROVIDE THE INFORMATION WHICH PRODUCT WAS USED ON THE INSTRUMENT. THE CUSTOMER SENT IN THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THE SAMPLE COULD NOT BE TESTED, BECAUSE IT WAS COMPLETELY HEMOLYZED UPON ARRIVAL. THE CUSTOMER ALSO RETURNED THE ALLLEGENDLY DEFECTIVE PRODUCT SAMPLE BUT AT THE TIME THE SAMPLE ARRIVED ON OUR PREMISES, IT WAS ALREADY EXPIRED. OUR QUALITY CONTROL LABORATORY TESTED THE LU(A) AND LU(B) ANTIGENS OF THEIR RETENTION SAMPLE OF BIOTESTCELL P1, P2 DURING THE PRODUT'S SHELF LIFE. BOTH SCREENING CELLS YIELDED A POSITIVE RESULT WITH SEARCLONE ANTI-LU(B) AND A NEGATIVE RESULT WITH ANTI-LU(A). THESE RESULTS CORRESPOND TO THE DETAILS OF THE ANTIGEN TABLE. THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED. THE COMPLAINT SAMPLE COULD NOT BE TESTED WITHIN ITS SHELF LIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911436 ↗
• MalfunctionNov 2, 2020False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THEY USED BIOTESTCELL 1&2 (REF #816014100, LOT #8035011-00) IN THE TUBE TEST AND DID NOT PICKUP AN ANTI-D. THE CUSTOMER STATED THAT THEY USED THE TUBE TEST FOR BOTH QC AND PATIENT SAMPLES WITH A PASSIVE ANTI-D. HE ALSO STATED THAT THE ANTI-D WAS PICKED UP WHEN THE REAGENT WAS USED ON THEIR IH-500. THE CUSTOMER USED IH BASIC QC AS CONTROL (QC). THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULT AND HE ALSO PROVIDED A TABLE WITH THEIR TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG LOT 8846130-05 USED BY THE CUSTOMER FOR POTENCY. THE TESTING WAS DONE IN PARALLEL TO A REFERENCE LOT (LOT #8948030-05). BOTH LOTS MET THE ACCEPTANCE CRITERION. THE RETENTION SAMPLE OF BIOTESTCELL 1&2 WAS TESTED FOR SPECIFICITY IN THE TUBE METHOD (30 MINUTES INDIRECT ANTIGLOBULIN TEST (IAT). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ADDITIONALLY THE D ANTIGENICITY OF THE RETENTION SAMPLE OF BIOTESTCELL 1&2 LOT #8035011-00 WAS TESTED. AGAIN, THE ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY WEAKENED D ANTIGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10769892 ↗
• MalfunctionJun 29, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WITH BIOTESTCELL 1&2 (REF 816014100, LOT 8015011-00) ON TANGO INFINITY. THE CUSTOMER STATED THAT THE PATIENT WAS TESTED AT ANOTHER FACILITY AND THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-K (KEL1). THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL 1&2 (REF 816065100, LOT 8015011-00) WITH SERACLONE ANTI-K IN THE TUBE TEST WITH AN INCUBATION FOR 5 MINUTES AT ROOM TEMPARATURE AND WITH A POLYCLONAL ANTI-K IN THE INDIRECT ANTIGLOBULIN TEST (IAT). CELL #1 (DONOR #(B)(6), K+K+) OF BIOTESTCELL 1&2 YIELDED A CORRECTLY POSITIVE RESULT IN BOTH TESTS. THE CUSTOMER DID NOT PROVIDE RESULT IMAGES OR THE LOG FILES FOR ANALYSING THE INSTRUMENT'S FUNCTION. LAST PREVENTIVE MAINTENANCE WAS IN JANUARY 2020. WITHOUT LOG FILES AN ANALYSIS OF THE INSTRUMENT'S FUNCTION IS NOT POSSIBLE. ACCORDING TO THE FIELD SERVICE ENGINEER THE INSTRUMENT IS RUNNING WITHIN SPECIFICATION. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE RETENTION SAMP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205434 ↗
• MalfunctionMay 14, 2020False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF ONE PATIENT SAMPLE ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-JKA, ANTI-FYA AND ANTI-E. THE CUSTOMER STATED THAT SAMPLE #(B)(6) WAS TESTED FOR ANTIBODY SCREENING AND IDENTIFICATION ON TANGO INFINITY. ALL TESTS WERE NEGATIVE. WHILE THE TANGO INFINITY WAS RUNNING THE CUSTOMER TESTED THE SAMPLE IN THE GEL METHOD OF A COMPETITOR. THE RESULTS WERE POSITIVE AND ANTI-E, ANTI-JK(A) AND ANTI-FY(A) COULD BE IDENTIFIED. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUC FOR INVESTIGATIONAL TESTINGT AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVES. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT SAMPLE ON TANGO INFINITY. CELL #2 OF BIOTESTCELL 1&2 SHOWED A CORRECTLY POSITIVE RESULT DUE TO THE E ANTIGEN AND THE JK(A) ANTIGEN. CELL #2 WHICH WERE SUPPOSED TO REACT POSITIVELY BECAUSE OF THE FY(A) ANTIGEN SHOWED A NEGATIVE REACTION. FURTHER TESTS OF THE PATIENT SAMPLE WERE NOT POSSIBLE, BECAUSE IT WAS DEPLETED. THE COMPLAINT SAMPLE BIOTESTCELL 1&2 SHOWED CORRECT RESULTS WITH THREE DIFFERENT SAMPLES CONTAING AN ANTI-E, AN ANTI-FY(A) AND ANTI-JK(A) ON TANGO INFINITY. THE AFFECTED TANGO IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10055460 ↗
• MalfunctionAug 7, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL 1&2 ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. THE CUSTOMER STATED THAT THE ANTIBODY COULD BE DETECTED IN THE ORTHO GEL METHOD. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 1&2. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER AND COULD CONFIRM THE CUSTOMER´S FINDING. FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE WERE NOT POSSIBLE, BECAUSE IT WAS USED UP. THE RETURNED PRODUCT SAMPLE AND OUR QC LAB'S RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WERE TESTED WITH DIFFERENT SAMPLES AND CONTROLS INCLUDING AN ANTI-E ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868279 ↗
• MalfunctionJul 11, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL 1&2 ON TANGO INFINITY. THE PATIENT HAS A KNOWN ANTI-E. THE CUSTOMER STATED THAT THE ANTIBODY COULD BE DETECTED IN THE GEL METHOD. THE CUSTOMER RETESTED THE PATIENT SAMPLE ON THE TANGO INFINITY AND RECEIVED A +/- REACTION WITH THE E HOMOZYGOUS SCREENING CELL OF BIOTESTCELL 1&2. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 1&2. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETURNED COMPLAINT SAMPLE AND COULD CONFIRM THE CUSTOMER´S FINDING. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED IN THE TUBE TECHNIQUE WITH DIFFERENT INCUBATION TIMES, TEMPERATURES AND MEDIA. THE PATIENT SAMPLE YIELDED NEGATIVE REACTIONS IN ALL TUBE ASSAYS. FURTHERMORE THE PATIENT SAMPLE WAS TESTED IN THE GEL TECHNIQUE AND YIELDED A POSITIVE REACTION. THE COMPLAINT AND THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WERE ALSO TESTED WITH DIFFERENT SAMPLES AND CONTROLS INCLUDING AN ANTI-E. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8779971 ↗
• MalfunctionMay 23, 2019False Negative Result

  THE CUSTOMER COMPLAINED WEAK REACTIONS WITH BIOTESTCELL 1&2, #8911011-00 WHEN TESTING ON TANGO INFINITY. ON THREE SAMPLES (#(B)(6)) TANGO INFINITY CALLED RESULTS AS NEGATIVE WHEN THEY WERE VISUALLY POSITIVE (DISCREPANT). A PANEL WAS PERFORMED MANUALLY AND SHOWED NON-SPECIFIC REACTIVITY, ALL COMMON ANTIBODIES WERE RULED OUT. THE CUSTOMER PROVIDED TWO PATIENT SAMPLES (#(B)(6)) FOR INVESTIGATIONAL TESTING AND ALSO THE ALLEGEDLY DEFECTIVE PRODUCT, BIOTESTCELL 1&2. UPON ARRIVAL ON OUR PREMISES ON MAY 7TH, 2019 , THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 WAS ALREADY EXPIRED (ON MAY 6TH, 2019). OUR QUALITY CONTROL LABORATORY TESTED DIFFERENT SAMPLES (POSITIVES AND NEGATIVES) ON TANGO INFINITY BY USING THEIR RETAIN SAMPLE OF BIOTESTCELL 1&2. A KNOWN ANTI-FYA, ANTI-JKA AND AN ANTI-D (SC II CONTROL) WERE ALSO TESTED. OUR LAB ALSO TESTED THE SAMPLES PROVIDED BY THE CUSTOMER AS WELL AS POSITIVES (ANTI-D) AND NEGATIVES. BIOTESTCELL 3, LOT 8915011-00 WAS USED FOR TESTING BECAUSE THE COMPLAINED LOT WAS ALREADY EXPIRED. ALL REACTIONS WERE CORRECT AND UNAMBIGUOUSLY READABLE BY TANGO INFINITY. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. POSITIVE AND NEGATIVE CONTROLS REACTED AS EXPECTED. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635522 ↗
• MalfunctionMay 29, 2018False Negative Result

  THE CUSTOMER REPORTED THAT A STRONG ANTIBODY SCREENING RESULT OF SAMPLE WAS CALLED (B)(6) WHEN TESTED WITH BIOTESTCELL 1&2 ON TANGO INFINITY. THE CUSTOMER REVIEWED THE RESULTS AND EDITED THIS RESULT TO (B)(6). ANOTHER WEAK (B)(6) RESULT (PASSIVELY ACQUIRED ANTI-D; RHOGAM) WAS ALSO CALLED NEGATIVE BY THE INSTRUMENT. THE CUSTOMER DID NOT EDIT THIS RESULT. THE CUSTOMER RETURNED THREE SAMPLES AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. AT THE TIME WE RECEIVED THE CUSTOMER'S SAMPLES ON OUR PREMISES, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE SAMPLES WITH THEIR RETENTION SAMPLE OF THE CURRENT LOT OF BIOTESTCELL 1&2 (LOT 8815011-00) ON TANGO INFINITY. ALL THREE SAMPLES YIELDED (B)(6) RESULTS. THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE BIOTESTCELL 1&2 LOT WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY WITHIN ITS SHELF LIFE AND REACTED AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548205 ↗
• MalfunctionMay 29, 2018False Negative Result

  THE CUSTOMER REPORTED THAT A STRONG ANTIBODY SCREENING RESULT OF SAMPLE WAS CALLED NEGATIVE WHEN TESTED WITH BIOTESTCELL 1&2 ON TANGO INFINITY. THE CUSTOMER REVIEWED THE RESULTS AND EDITED THIS RESULT TO POSITIVE. ANOTHER WEAK POSITIVE RESULT (PASSIVELY ACQUIRED ANTI-D; RHOGAM) WAS ALSO CALLED NEGATIVE BY THE INSTRUMENT. THE CUSTOMER DID NOT EDIT THIS RESULT. THE CUSTOMER RETURNED THREE SAMPLES AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. AT THE TIME WE RECEIVED THE CUSTOMER'S SAMPLES ON OUR PREMISES, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE SAMPLES WITH THEIR RETENTION SAMPLE OF THE CURRENT LOT OF BIOTESTCELL 1&2 (LOT 8815011-00) ON TANGO INFINITY. ALL THREE SAMPLES YIELDED POSITIVE RESULTS. THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE BIOTESTCELL 1&2 LOT WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY WITHIN ITS SHELF LIFE AND REACTED AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548158 ↗
• MalfunctionNov 16, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT SAMPLE WITH A KNOWN ANTI-K WHEN TESTING WITH BIOTESTCELL 1&2 ON TANGO OPTIMO. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE WHICH HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE MATERIAL PROVIDED BY CUSTOMER ON OUR PREMISES, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE PROVIDED COMPLAINED SAMPLE WITH THE PATIENT SAMPLE ON TANGO OPTIMO AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY THE COMPLAINT SAMPLE WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS, INCLUDING ANTI-K ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RETENTION SAMPLE OF BIOTESTCELL 1&2 WAS ALREADY TESTED WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-K, WITHIN SHELF LIFE. ALL RESULTS WERE AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036310 ↗
• MalfunctionApr 19, 2017False Negative Result; Incorrect Or Inadequate Test Results; Defective Device

  THE CUSTOMER REPORTED THAT SHE MISSED AN ANTI-S WHEN USING BIOTEST CELL 1 AND 2 ON TANGO INFINITY. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ALSO THE PATIENT SAMPLE WHICH HAD CAUSED A FALSE NEGATIVE TEST RESULT FOR INVESTIGATIONAL TESTING. THE CUSTOMER ALSO RETURNED THE AFFECTED ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II AND THE AFFECTED LOW IONIC STRENGTH SOLUTION (LISS) MLB2. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE ON TANGO INFINITY WITH THE REAGENTS PROVIDED BY THE CUSTOMER AND YIELDED CORRECT POSITIVE RESULTS. THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALSO TESTED WITH DIFFERENT SAMPLES AND CONTROLS, E.G. AN ANTI-S. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION DURING TESTING ON TANGO INFINITY. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL 1 AND 2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF BOTH ALLEGEDLY DEFECTIVE LOTS. THE AFFECTED TANGO INFINITY WAS INSPECTED BY OUR FIELD SERVICE ENGINEERS. A METROLOGY CHECK WAS PERFORMED ACCORDING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6502728 ↗
• MalfunctionApr 13, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT SAMPLE WITH BIOTESTCELL 1&2 WHEN TESTING ON TANGO INFINITY. THE CUSTOMER REPORTED THAT A SAMPLE WAS RUN ON TANGO INFINITY FOR ANTIBODY SCREENING AND YIELDED A NEGATIVE TEST RESULT. UPON REPEATING, THE SAMPLE YIELDED A POSITIVE TEST RESULT. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT SENT BACK THREE PATIENT SAMPLES WHICH HAD CAUSED FALSE NEGATIVES. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED BIOTESTCELL 1&2 SAMPLE WITH DIFFERENT PATIENT SAMPLES AND CONTROLS, INCLUDING AN ANTI-D, AND -E ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ONCE THE PATIENT SAMPLES SENT BACK FROM THE CUSTOMER ARRIVED IN OUR QC LAB, THEY WERE TESTED ON TANGO INFINITY, MANUALLY AND IN IH-CARD. A CLEAR ALLOCATION FOR THESE THREE SAMPLES FROM THE CUSTOMER WAS NOT POSSIBLE SO THE OBSERVATION OF THE CUSTOMER WAS CONFIRMED. A RELEVANT REFERENCE CAN BE FOUND IN THE INSTRUCTION FOR USE (IFU): "NEGATIVE REACTIONS WILL BE OBTAINED IF THE SAMPLE CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489249 ↗
• MalfunctionApr 13, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT SAMPLE WITH BIOTESTCELL 1&2 WHEN USED ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-K. THE SAMPLE WAS RUN ON TANGO INFINITY FOR ANTIBODY SCREEN AND IDENTIFICATION AT THE SAME TIME. THE PATIENT WAS A KNOWN ANTI-K. THE SCREENING RESULT WAS NEGATIVE AND THE IDENTIFICATION PANEL WAS POSITIVE FOR ANTI-K. ONCE THE TEST WAS REPEATED, THE SCREENING RESULT WAS POSITIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED BIOTESTCELL 1&2 SAMPLE WITH DIFFERENT PATIENT SAMPLES AND CONTROLS, INCLUDING AN ANTI-D, -E AND -K ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. WHEN THE PATIENT SAMPLE WAS TESTED, IT YIELDED AN UNAMBIGOUS RESULT SHOWING AN ANTI-K. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEG

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489247 ↗
• MalfunctionApr 13, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING TEST OF A PATIENT SAMPLE WITH BIOTEST CELL 1 AND 2 WHEN TESTING ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS AN ANTI-E. THE CUSTOMER REPORTED THAT WHEN THE SAMPLE OF A KNOWN ANTI-E WAS RUN ON TANGO INFINITY FOR ANTIBODY SCREEN AND IDENTIFICATION AT THE SAME TIME, THE SCREENING RESULT WAS NEGATIVE BUT THE PANEL WAS 1+ POSITIVE FOR ANTI-E. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT SENT BACK THREE PATIENT SAMPLES WHICH HAD CAUSED FALSE NEGATIVES. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED BIOTEST CELL 1 AND 2 SAMPLE WITH DIFFERENT PATIENT SAMPLES AND CONTROLS, INCLUDING AN ANTI-D, AND -E ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ONCE THE PATIENT SAMPLES SENT BACK FROM THE CUSTOMER ARRIVED IN OUR QC LAB, THEY WERE TESTED ON TANGO INFINITY, MANUALLY AND IN IH-CARD. A CLEAR ALLOCATION FOR THESE THREE SAMPLES FROM THE CUSTOMER WAS NOT POSSIBLE SO THE OBSERVATION OF THE CUSTOMER WAS CONFIRMED. A RELEVANT REFERENCE CAN BE FOUND IN THE INSTRUCTION FOR USE (IFU): "NEGATIVE RE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489245 ↗
• MalfunctionApr 10, 2017Device Expiration Issue; False Negative Result; Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED THAT SHE MISSED AN ANTI-JK(A) WHEN USING BIOTEST CELL 1&2 ON TANGO INFINITY DURING YEARLY CORRELATION QC. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL 1&2 FOR INVESTIGATIONAL TESTING BUT RETURNED THE PATIENT SAMPLE WHICH HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE OUR QC LAB'S RETENTION SAMPLE WAS NOT TESTED. UPON RECEIVING THE PATIENT SAMPLE IN (B)(4), OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF THE CURRENT BIOTEST CELL 1&2 LOT WITH THE PATIENT SAMPLE ON TANGO INFINITY AND COULD CONFIRM THE CUSTOMER´S RESULT. UPON VISUAL ASSESSMENT THE REACTION WAS NOT CLEARLY NEGATIVE. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED IN THE TUBE TECHNIQUE AND YIELDED A +/- REACTION. THE PATIENT SAMPLE WAS ALSO TESTED IN THE IH-GEL METHOD AND YIELDED WEAK POSITIVE RESULTS. THE POSITIVE REACTION WAS A BIT STRONGER WHEN USING ENZYME TREATED REAGENT RED BLOOD CELLS IN THE IH-GEL SYSTEM. THESE TEST RESULTS STRONGLY INDICATE THAT THE MISSED ANTI-JK(A) IS A WEAK REACTING ANTIBODY. THE INSTRUCTION FOR USE CONTAINS A CORRES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474753 ↗
• MalfunctionFeb 15, 2017False Negative Result; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AN ANTI-FY(A) OF A CONTROL REAGENT WAS MISSED WHEN USING BIOTEST CELL 1&2 ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE CONTROL SHOWED A POSITIVE RESULT IN THE FIRST RUNS ON TANGO OPTIMO, BUT DURING A RE-TESTING THE CONTROL YIELDED A FALSE NEGATIVE TEST RESULT. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT, THE CONTROL THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT AND ALSO THE AFFECTED ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II FOR INVESTIGATIONAL TESTING. UPON ARRIVAL ON OUR PREMISES, THE VIAL CONTAINING THE SUPPOSEDLY DEFECTIVE PRODUCT WAS COMPLETELY LEAKED OUT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE CONTROL WITH THEIR RETAINED SAMPLE OF BIOTEST CELL 1&2 ON TANGO OPTIMO. IT SHOWED A CORRECT POSITIVE RESULT WITH CELL #1 OF BIOTEST CELL 1&2. THE RETAINED SAMPLE OF BIOTEST CELL 1&2 WAS ALSO TESTED WITH DIFFERENT CONTROLS AND SAMPLES, E.G. ANTI-FY(A). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY THE AFFECTED ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II PROVIDED BY THE CUSTOMER WAS ALSO TESTED AND YIELDED CORRECT RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6331282 ↗
• MalfunctionJan 13, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE (PRENATAL, WITH AN ANTI-S) YIELDED A FALSE NEGATIVE ANTIBODY TEST IN BOTH TANGO OPTIMO AND TANGO INFINITY WHEN TESTED WITH BIOTESTCELL 1 & 2, # 8643021-00. THE CUSTOMER WAS ABLE TO DETECT THE ANTIBODY IN THE TUBETEST WITH PEG (HETEROZYGOUS CELL REACTED 1+ AND 2+, HOMOZYGOUS CELL REACTED 2+). THE CUSTOMER SENT IN THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING AS WELL AS A SAMPLE OF THE ALLEGEDLY DEFECTIVE BIOTESTCELL LOT AND ALSO THE SOLIDSCREEN II AHG USED IN THIS FALSE NEGATIVE TEST. AT THE TIME THE MATERIAL ARRIVED ON OUR PREMISES, THE AFFECTED BATCH HAD ALREADY EXPIRED. THE AFFECTED LOT HAD ALREADY EXPIRED AT THE TIME THE CUSTOMER FILED HER COMPLAINT. ALTHOUGH THE ALLEGEDLY DEFECTIVE PRODUCT SAMPLE WAS ALREADY EXPIRED, IT WAS TESTED IN OUR QUALITY CONTROL LABORATORY ON TANGO OPTIMO AND TANGO INFINITY AND YIELDED ON BOTH INSTRUMENTS A NEGATIVE REACTION. AN ANTI-S USED IN THIS TEST REACTED CORRECTLY POSITIVE. THE AHG RETURNED BY THE CUSTOMER WAS USED FOR TESTING. WHEN TESTED WITH REFERENCE BATCH BIOTESTCELL 1&2 # 867021-00 - THAT WAS WITHIN ITS SHELF LIFE - THE PATIENT SAMPLE SHOWED A CORRECT 1+ POSITIVE RESULT ON BOTH INSTRUMENTS. THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249276 ↗
• MalfunctionJan 13, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE (PRENATAL, WITH AN ANTI-S) YIELDED A FALSE NEGATIVE ANTIBODY TEST IN BOTH TANGO OPTIMO AND TANGO INFINITY WHEN TESTED WITH BIOTESTCELL 1&2, # 8647021-00. THE CUSTOMER WAS ABLE TO DETECT THE ANTIBODY IN THE TUBE WITH PEG (HETEROZYGOUS CELL REACTED 1+ AND 2+, HOMOZYGOUS CELL REACTED 2+). THE CUSTOMER SENT IN THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING AND BIOTESTCELL 1&2, # 8643021-00, THAT WAS ALREADY EXPIRED, BUT NOT THE COMPLAINED MATERIAL BIOTESTCELL 1&2, # 8647021-00. THE SOLIDSCREEN II AHG, THAT WAS USED AS THE COMPLAINT OCCURRED, WAS ALSO SENT IN. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL 1&2 # 8647021-00. THE PATIENT SAMPLE SHOWED A CORRECT 1+ POSITIVE RESULT WITH RRBC 2 ON BOTH INSTRUMENTS. THE SOLDISCREEN II AHG RETURNED BY THE CUSTOMER WAS USED FOR THIS TESTING. THE PATIENT SAMPLE WAS ALSO TESTED IN THE TUBE TEST (IMMEDIATELY SPIN (RZT), LISS 10 MIN 37 ° C AND IN LISS-IAT) AND REACTED NEGATIVELY, ALSO IN THE LISS / COOMBS GEL CARD THE REACTION WAS NEGATIVE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 FUNCTIONS CORRECTLY. A REVIEW OF TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6249168 ↗