Biotestcell®-I 11 816021100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07611969952434), received between Jun 19, 2018 and Feb 17, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A POSITIVE ANTIBODY SCREENING TEST SHOWED COMPLETELY NEGATIVE RESULTS WITH THE PANEL CELLS OF BIOTESTCELL-I11 WHEN TESTED ON TANGO INFINITY. THE CUSTOMER DID NOT PROVIDE A PRODUCT SAMPLE OF THE COMPLAINED PRODUCT FOR INVESTIGATIONAL TESTING BUT PROVIDED THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH THREE KNOWN ANTIBODIES (ANTI-E, ANTI-S AND ANTI-FYA), POSITIVE AND NEGATIVE CONTROL AND DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AT THE TIME OUR QC LAB RECEIVED THE PATIENT SAMPLE FOR INVESTIGATION, THE SUPPOSEDLY DEFECTIVE BIOTESTCELL-I11 LOT WAS ALREADY EXPIRED. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER WITH THE CURRENT LOT OF BIOTESTCELL-I11 (LOT #9304011-00) ON TANGO INFINITY. THE REACTIONS WERE CLEARLY NEGATIVE. THE PATIENT SAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396368 ↗
• MalfunctionFeb 17, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A POSITIVE ANTIBODY SCREENING TEST SHOWED COMPLETELY NEGATIVE RESULTS WITH THE PANEL CELLS OF BIOTESTCELL-I11 WHEN TESTED ON TANGO INFINITY. THE CUSTOMER DID NOT PROVIDE A PRODUCT SAMPLE OF THE COMPLAINED PRODUCT FOR INVESTIGATIONAL TESTING BUT PROVIDED THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH THREE KNOWN ANTIBODIES (ANTI-E, ANTI-S AND ANTI-FYA), POSITIVE AND NEGATIVE CONTROL AND DONOR SAMPLES ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AT THE TIME OUR QC LAB RECEIVED THE PATIENT SAMPLE FOR INVESTIGATION, THE SUPPOSEDLY DEFECTIVE BIOTESTCELL-I11 LOT WAS ALREADY EXPIRED. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER WITH THE CURRENT LOT OF BIOTESTCELL-I11 (LOT #9304011-00) ON TANGO INFINITY. THE REACTIONS WERE CLEARLY NEGATIVE. THE PATIENT SAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395241 ↗
• MalfunctionMar 3, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE OR ONLY WEAK POSITIVE RESULTS OF CELL #9 (DONOR (B)(6) WITH ANTI-S (MNS4) REAGENTS. ACCORDING TO THE ANTIGEN TABLE CELL #9 WAS SS. THE CUSTOMER STATED THAT CELL #9 SHOWED THE NEGATIVE RESPECTIVELY TOO WEAK POSITIVE RESULTS WITH 4 OF 6 LISTED ANTISERA. BASED ON THE TEST RESULTS THE CUSTOMER SUSPECTED A WEAKENING OR VARIANT OF THE S ANTIGEN OF DONOR #(B)(6). OUR QUALITY CONTROL LABORATORY TESTED THE S AND S ANTIGENS OF CELL #9 COMPARED TO TWO OTHER HETEROZYGOUS CELLS (I3/I8) WITH DIFFERENT ANTISERA (POLYCLONAL AND MONOCLONAL), SINCE AN ATTENUATION OR VARIANT IS NOT NECESSARILY DETECTED WHEN USING ONLY A MONOCLONAL REAGENT. FOR FURTHER CELL #9 (SS) WAS TESTED IN COMPARISON TO CELL #3 (SS) AND CELL #8 (SS) IN ANOTHER METHOD (ID-CARD). AN ID-ANTIGEN PROFILE III (INCLUDING ANTI-S AND ANTI-S HUMAN POLYCLONAL) WAS CARRIED OUT. IN BOTH TEST METHODS NO SIGNIFICANT DIFFERENCES BETWEEN THE 3 CELLS WERE FOUND. THE CUSTOMER SENT IN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. AT THE TIME WE RECEIVED THE COMPLAINT SAMPLE CELL #9 IT WAS ALREADY EXPIRED. BUT NEVERTHELESS, OUR QUALITY CONTROL LABORATORY TESTED IT WITH DIFFERENT MONOCLONAL AND POLYCLONAL ANTI-S R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403203 ↗
• MalfunctionJan 28, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE ANTIBODY SCREEN FOR ANTI-C WITH BIOTESTCELL 3 (P2 AND P3 NEGATIVE) AND WITH BIOTESTCELL I11 WHEN TESTED ON TANGO INFINITY. IN GEL SCREEN AND PANEL THE ANTI-C WAS DETECTED. THE QC WORKED FOR ALL CELLS THE DAY OF TESTING. THE EXACT DATE OF EVENT IS NOT KNOWN. THE CUSTOMER DID NOT PROVIDE RESULT IMAGES. WE REQUESTED FURTHER INFORMATION REGARDING THE AFFECTED TANGO INFINITY. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE COMPLAINT THE SUPPOSEDLY DEFECTIVE LOT WAS EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE IN PARALLEL WITH THE CURRENT LOT OF BIOTESTCELL-I11 AND DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY, E.G. DIFFERENT ANTI-C ANTIBODIES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. EVEN THE EXPIRED LOT OF BIOTESTCELL-I11 SHOWED CORRECT RESULTS WITH THE VARIOUS ANTI-C SERA. WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT, THE ROOT CAUSE ANALYSIS IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242911 ↗
• MalfunctionSep 1, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF CELL #1 (DONOR #: (B)(6)) OF BIOTESTCELL-I11 WITH THE ANTI-LE(B) REAGENT OF A COMPETITOR. ACCORDING TO THE ANTIGEN WORKSHEET CELL #1 IS LEA-B+. THE CUSTOMER STATED THAT SHE USED CELL #1 AS A POSITIVE CONTROL FOR THE ANTI-LE(B) REAGENT OF THE COMPETITOR. THE CUSTOMER STATED THAT CELL #2 (DONOR (B)(6)) OF BIOTESTCELL 1&2, WHICH IS ALSO LE(B) POSITIVE YIELDED A CORRECT POSITIVE RESULT. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE BIOTESTCELL-I11 FOR INVESTIGATIONAL TESTING BUT NOT THE ANTI-LE(B) REAGENT OF THE COMPETITOR. AT THE TIME WE RECEIVED THE COMPLAINT SAMPLE THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE WITH SERACLONE ANTI-LE(B). THE TEST WAS PERFORMED MANUALLY IN THE TUBE TECHNIQUE WITH AN INCUBATION OF 15 MINUTES AT ROOM TEMPERATURE ACCORDING TO THE INSTRUCTION FOR USE OF SERACLONE ANTI-LE(B). CELL #1 OF BIOTESTCELL-I11 YIELDED A CORRECT POSITIVE RESULT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECO

  Patient problems: Test Result

  MAUDE report 10475479 ↗
• MalfunctionJun 23, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF CELL #10 (DONOR #: (B)(6)) OF BIOTESTCELL-I11 WITH THE ANTI-M REAGENT OF A COMPETITOR. ACCORDING TO THE ANTIGEN WORKSHEET CELL #10 IS M+N+. THE CUSTOMER STATED THAT SHE PERFORMED THE TEST MANUALLY IN THE TUBE TECHNIQUE AND INCUBATED FOR 30 MINUTES, BUT YIELDED A NEGATIVE RESULT. SHE ALSO STATED THAT CELL #4 (DONOR (B)(6)), WHICH IS ALSO M+N+ YIELDED A CORRECTLY POSITIVE RESULT. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE BIOTESTCELL-I11 FOR INVESTIGATIONAL TESTING, BUT RETURNED BIOTESTCELL-I11 LOT 8009011-00 (EXPIRY DATE 2020-04-20) IN THE BOX AND THE WORKSHEET OF LOT 8017011-00. BIOTESTCELL-I11 LOT 8009011-00 AND LOT 8017011-00 CONTAINED THE SAME DONOR (DONOR #: (B)(6)) FOR CELL #10. THE CUSTOMER DID NOT RETURN THE ANTI-M REAGENT OF THE COMPETITOR. ALTHOUGH BIOTESTCELL-I11 LOT 8009011 WAS EXPIRED, OUR QUALITY CONTROL LABORATORY TESTED THE REAGENT RED BLOOD CELLS (RRBC) PROVIDED BY THE CUSTOMER WITH TWO DIFFERENT LOTS OF SERACLONE ANTI-M. THE TEST WAS PERFORMED MANUALLY IN THE TUBE TECHNIQUE WITH AN INCUBATION OF 30 MINUTES AT ROOM TEMPERATURE ACCORDING TO THE INSTRUCTION FOR USE. ALL M ANTIGEN POSITIVE REAGENT RED BLOOD CELLS (CELL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183848 ↗
• MalfunctionDec 5, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULT OF CELL #4 OF BIOTESTCELL-I11 WITH ANTI-LE(B) REAGENTS. BECAUSE CELL #4 (DONOR NO. 103355) IS LISTED AS LE(B) POSITIVE IN THE ANTIGEN PROFILE WORKSHEET, THE CUSTOMER ASSUMED THAT THIS WAS LIKELY A PRINTING ERROR ON THE WORKSHEET. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE ANTI-LE(B) REAGENTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED CELL #4 OF THEIR BIOTESTCELL-I11 RETENTION SAMPLE WITH THE BLOOD GROUPING REAGENT SERACLONE ANTI-LE(B) AND GOT ONLY A +/- REACTION. THIS IS A QUESTIONABLE RESULT AND NOT A CLEAR POSITIVE REACTION. FURTHER TESTS CONFIRMED THAT THE SAMPLE OF CELL #4 DOES NOT ALWAYS GIVE CLEARLY POSITIVE RESULTS WITH ANTI-LE(B) REAGENTS. BASED ON THE TEST RESULTS THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BUT BASED ON THE CONFIRMED COMPLAINT A DEVIATION WAS INITIATED AND THE DONOR WAS BLOCKED. NO FURTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED. THERE IS NO RISK FOR PATIENTS. ANTI-LE(B) ANTIBODIES BELONG TO THE GROUP OF IGM'S, ARE THEREFO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415237 ↗
• MalfunctionNov 27, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF ONE SPECIMEN WHEN TESTED WITH BIOTESTCELL-I11 ON THE TANGO INFINITY DURING INSTRUMENT VALIDATION. THE CUSTOMER STATED THAT THE SPECIMEN CONTAINED AN ANTI-C WHICH REACTED POSITIVE IN THE GEL METHOD. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE SPECIMEN THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. ACCORDING TO THE BIOTESTCELL-I11 ANTIBODY IDENTIFICATION TABLE CELLS #1, #3, #5 AND #9 ARE C POSITIVE AND THEREFORE SUPPOSED TO YIELD A POSITIVE REACTION. OUR QUALITY CONTROL LABORATORY TESTED THE PRODUCT SAMPLE RETURNED BY THE CUSTOMER AS WELL AS THEIR RETENTION SAMPLE WITH THE SPECIMEN ON TANGO INFINITY AND YIELDED WEAK POSITIVE REACTIONS WITH CELL #1, #3, AND #5. ONLY CELL #9 SHOWED A FALSE NEGATIVE REACTION. THE RETURNED PRODUCT SAMPLE AS WELL AS THE RETENTION SAMPLE OF BIOTESTCELL-I11 WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY THE SPECIMEN WAS TESTED IN THE IH-GEL METHOD. AGAIN CELL #1, #3 AND #5 SHOWED WEAK POSITIVE REACTIONS WHILE CELL #9 REACTED NEGATIVELY. FURT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9382751 ↗
• MalfunctionNov 11, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON HER TANGO INFINITY WHEN USING BIOTESTCELL-I11. THE CUSTOMER STATED THAT WITHIN HER VALIDATION OF HER NEW TANGO INFINITY A SAMPLE (#922062) WITH AN ANTI-C AND ANTI-E SHOWED FALSE NEGATIVE RESULTS WITH BIOTESTCELL-I11. THE SAMPLE YIELDED WEAK POSITIVE REACTIONS IN THE GEL METHOD OF A COMPETITOR. BUT NOT ALL C (RH2) AND E (RH5) POSITIVE REAGENTS RED BLOOD CELLS THAT WERE SUPPOSED TO YIELD POSITIVE REACTIONS DUE TO THE ANTIGEN PATTERN SHOWED POSITIVE REACTIONS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECORDED THIS COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE A TESTING OF THE RETENTION SAMPLE OF THE COMPLAINED LOT WAS NOT PERFORMED BY OUR QUALITY CONTROL LABARATORY. THE DELAYED RECORDING OF THIS COMPLAINT IS PROCESSED WITHIN OUR DEVIATION SYSTEM. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE DID NOT RECEIVE ANY FURTHER COMPLAINTS RELATED TO THIS ISSUE. REGARDING THE AFFECTED TA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9303798 ↗
• MalfunctionOct 11, 2019False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS ON HER TANGO INFINITY WHEN USING BIOTESTCELL-I11. THE CUSTOMER STATED THAT WITHIN HER VALIDATION OF HER NEW TANGO INFINITY A SAMPLE WITH AN ANTI-FY(B) SHOWED FALSE NEGATIVE RESULTS WITH BIOTESTCELL-I11. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WAS NOT TESTED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE DID NOT RECEIVE ANY FURTHER COMPLAINTS RELATED TO THIS ISSUE. REGARDING THE AFFECTED TANGO INFINITY: RESULT IMAGES FROM AVAILABLE SAMPLES WERE REVIEWED (SOURCED FROM SENT DATABASE VALIDATE.PHB = LAB JOURNAL). THE IMAGES FROM COMPLAINT SAMPLES ARE SHOWING NEGATIVE RESULTS, WHICH CAN BE VISUALLY CONFIRMED AS NEGATIVE. THE INSTRUMENT WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND LOG FILES COLLECTED. METROLOGY WAS RUN AND VERIFIED THAT ALL WERE WITHIN MANUFA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178405 ↗
• MalfunctionApr 15, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF CELL #10 OF THE PRODUCT BIOTESTCELL-I11. THE CUSTOMER STATED THAT CELL #10 WAS TESTED MANUALLY WITH SERACLONE ANTI-M AND YIELDED INTO NEGATIVE TEST REACTIONS INSTEAD OF POSITIVE TEST REACTIONS. THE CUSTOMER PROVIDED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL-I11 NOR THE INVOLVED SERACLONE ANTI-M REAGENT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THIS BIOTESTCELL-I11 LOT MANUALLY WITH SERACLONE ANTI-M. CELL #10 OF BIOTESTCELL-I11 SHOWED A CORRECTLY POSITIVE RESULT. TESTING BY THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 . A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF BOTH ALLEGEDLY DEFECTIVE LOTS. NO INSTRUMENTS WERE INVOLVED BECAUSE OF A MANUALLY TEST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8513730 ↗
• MalfunctionMar 19, 2019False Negative Result; Defective Device

  THE CUSTOMER REPORTED DISCREPANT TEST RESULTS BETWEEN TANGO OPTIMO AND A COMPETITOR DEVICE. WHEN USING THE ORTHO MANUAL GEL METHOD, AN ANTI-E AND AN ANTI-C WERE IDENTIFIED. WHEN USING BIOTESTCELL I11 ON TANGO OPTIMO JUST AN ANTI-E WAS FOUND BUT NOT AN ANTI-C. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF BIOTESTCELL I11 WITH DIFFERENT SAMPLES AND CONTROLS (ANTI-D, ANTI-C, NEG. CONTROL) ON TANGO OPTIMO. FURTHERMORE A KNOWN ANTI-E AND AN ANTI-C SAMPLE WERE TESTED. BOTH ANTIBODIES WERE FOUND TO BE POSITIVE AND ALL OTHER CONTROLS REACTED AS EXPECTED. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL-I11. THE SAMPLES ARRIVED ON OUR PREMISES ON MARCH 06, 2019 AND BY THAT TIME THE PRODUCT WAS ALREADY EXPIRED (MARCH 03, 2019). UPON ARRIVAL AT BMD, THE REAGENT RED BLOOD CELLS I4, I8 AND I9 WERE COMPLETELY LEAKED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETURNED SAMPLES (B)(6). THE LEAKED BOTTLES WERE REPLACED WITH QC RETENTION SAMPLES. IN ADDITION A REFERENCE BATCH WAS ALSO TESTED AND BOTH TEST RESULTS CONFIRMED THE FI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431336 ↗
• MalfunctionJul 26, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH AN ANTI-D WHEN TESTED WITH BIOTEST CELL-I11 IN THE MANUAL TEST METHOD. THE CUSTOMER STATED THAT THE ANTI-D YIELDED A CORRECTLY POSITIVE RESULT WITH BIOTEST CELL-I11 ON TANGO INFINITY. FOR THE MANUAL TEST METHOD THE CUSTOMER HAD USED BIOTEST CELL-I11 AND THE ANTI-HUMAN GLOBULIN FROM A COMPETITOR. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE INFORMATION THAT THE FALSE POSITIVE REACTION OCCURRED IN THE MANUAL METHOD AND NOT ON TANGO INFINITY, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS EXPIRED. THEREFORE OUR QUALITY CONTROL LABORATORY'S RETENTION SAMPLE WAS NOT TESTED MANUALLY. WITHIN THE SHELF LIFE OF BIOTEST CELL-I11 OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-D FROM A PROFICIENCY TESTING 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 THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL-I11 FUNCTI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7721667 ↗
• MalfunctionJun 19, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN IMMUCOR ECHO AND TANGO INFINITY. CUSTOMER RAN A PATIENT SAMPLE THAT WAS 4+ POS FOR ANTI-JKA ON TWO DIFFERENT IMMUCOR ANALYZERS AND YIELDED A POSITIVE RESULT. TESTING THE SAME TUBE WAS RUN ON TANGO INFINITY WITH BIOTESTCELL 3, # 8815021-00 AND BIOTESTCELL-11, #8817011-00 AND THE RESULTS WERE NEGATIVE. THE SAME SAMPLE WAS RUN ON A SECOND TANGO INFINITY AND THE RESULT WERE ALSO NEGATIVE. THE CUSTOMER DID NEITHER PROVIDE THE PATIENT SAMPLES HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING NOR THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 WITH DIFFERENT SAMPLES AND CONTROLS (E.G.: ANTI-D, ANTI-JKA) ON TANGO INFINITY. THE REAGENTS THAT WERE USED FOR TESTING ON CUSTOMERS SITE WERE ALSO USED FOR QC TESTING. ALL TEST RESULTS WERE AS EXPECTED, ALL POSITIVE REACTIONS WERE CLEARLY POSITIVE, NO IRREGULARITIES WERE FOUND. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613032 ↗
• MalfunctionJun 19, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE ANTIBODY SCREENING RESULTS FOR ANTI-JKA USING BIOTESTCELL -I 11 PANEL LOT 8817011-00 ON TANGO INFINITY, WHEREAS ON IMMUCOR ANALYZER THE ANTIBODY SCREENING AND PANEL RESULTS WERE REPORTED TO BE POSITIVE (3+). THE CUSTOMER CALLED IN STATING SHE RAN NEW PATIENT ANTIBODY SCREEN ON BOTH TANGO INFINITY'S ON SITE. THE ANTIBODY SCREEN WAS NEGATIVE. WHEN THE SAMPLE WAS RAN ON THE IMMUCOR ECHO THE ANTIBODY SCREEN WAS 3+ POSITIVE. THE ANTIBODY PANEL PERFORMED ON THE IMMUCOR ECHO WAS POSITIVE AND DEMONSTRATED AN ANTI-JKA. THE ANTIBODY PANEL USED ON TANGO INFINITY S/N (B)(4) WAS BIOTESTCELL-I 11 LOT #8817011-00. THE RESULTS WERE NEGATIVE. THE CUSTOMER DID NEITHER PROVIDE THE PATIENT SAMPLES HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING NOR THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 WITH DIFFERENT SAMPLES AND CONTROLS (E.G. : ANTI-D, ANTI-JKA) ON TANGO INFINITY. THE REAGENTS THAT WERE USED FOR TESTING ON CUSTOMERS SITE WERE ALSO USED FOR QC TESTING. ALL TEST RESULTS WERE AS EXPECTED, ALL POSITIVE REACTIONS WERE CLEARLY POSITIVE, NO IRREGULARITIES WE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613030 ↗