Biotestcell®-I 11 Plus 816022100Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07611969952441), received between Sep 21, 2016 and Sep 25, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT ANTIBODY DETECTION RESULTS AND FALSE NEGATIVE RESULTS ON ONE PATIENT USING BIOTESTCELL I11-PLUS ON TANGO INFINITY. ONE PATIENT SAMPLE (B)(6) WAS TESTED ON (B)(6) 2024 ON THE TANGO INFINITY WITH BIOTESTCELL 3, LOT 9429011-00. THE TEST RESULT WAS: P1 WAS EDITED FROM +/- TO 1+, P2 = 1+, P3 WAS NEGATIVE. THE SAME SAMPLE WAS TESTED USING THE SAME INSTRUMENT ON THE SAME DAY WITH BIOTESTCELL-I11 PLUS. THE TEST RESULT SHOWED THAT CELLS 1 - 3 WERE +/- BUT EDITED TO 1+. THE CUSTOMER NOTED THAT CELL 4 APPEARED TO BE POSITIVE BUT WAS INTERPRETED AS NEGATIVE BY THE INSTRUMENT. WE WERE INFORMED THAT THE PATIENT RECEIVED RHOGAM DURING THE 1ST WEEK OF (B)(6) 2024. THE RETENTION SAMPLE OF THE COMPLAINED PRODUCT BIOTESTCELL I11-PLUS WAS TESTED DURING ITS SHELF-LIFE. BIOTESTCELL-I 11 PLUS, LOT 9430011-00 WAS TESTED WITH 4 KNOWN ANTIBODIES (ANTI-C, ANTI-FYA, ANTI-K (DETERMINED IN DOUBLE) AND SOLIDSCREEN II CONTROL). ALSO, 3 DONOR SAMPLES SUPPOSED TO BE ANTIBODY FREE WERE TESTED AND ADDITIONALLY SOLIDSCREEN II NEGATIVE CONTROL. ALL TEST RESULTS WERE WITHIN EXPECTATIONS. THE TESTS CARRIED OUT IN DOUBLE DETERMINATION ACHIEVED THE SAME TEST RESULTS (+/- 1 REACTION STRENGTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299279 ↗
• MalfunctionJul 23, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A PATIENT SAMPLE THAT HAD A POSITIVE ANTIBODY SCREEN ON TANGO INFINITY WHEN USING BIOTESTCELL 3. THE SCREENING WAS REPEATED AND YIELDED A NEGATIVE. RESULT. TESTING WAS REPEATED THE NEXT DAY USING THE SAME TANGO INFINITY AND THE SAME BIOTESTCELL 3 VIAL. ALL CELLS WERE NEGATIVE (PLEASE ALSO SEE RELATED REPORTS 9610824-2024-00028 AND 9610824-2024-00029) . FURTHERMORE ALL PANEL CELLS USING BIOTESTCELL I-11 PLUS WERE NEGATIVE. A CONSULTED REFERENCE LABORATORY IDENTIFIED A WARM AUTO ANTIBODY. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED LOT OF BIOTESTCELL 3 WAS ALREADY EXPIRED. THEREFORE OUR QUALITY CONTROL DEPARTMENT TESTED TWO KNOWN ANTIBODIES (ANTI-K, ANTI-C), A POSITIVE CONTROL (SOLID SCREEN II CONTROL) AND A NEGATIVE CONTROL (SOLID SCREEN II NEGATIVE CONTROL) WITH BIOTESTCELL I-11 PLUS.. ALL REACTIONS OF THE REAGENT RED BLOOD CELLS WERE CLEARLY POSITIVE WITH THE CORRESPONDING ANTIBODY. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805759 ↗
• MalfunctionJul 16, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT THEIR BIOTESTCELL I-11 PLUS PANEL YIELDING NEGATIVE REACTIONS ON TANGO INFINITY.THE CUSTOMER ANNOUNCED TO PROVIDE A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I-11 PLUS FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITHIN THE SHELF-LIFE. THE RETENTION SAMPLE WAS TESTED WITH THREE KNOWN ANTIBODIES (ANTI-K, ANTI-FYA AND ANTI-C). ALL REACTIONS OF THE REAGENT RED BLOOD CELLS SHOWED CLEARLY POSITIVE REACTIONS WITH THE CORRESPONDING ANTIBODY. FURTHERMORE, SOLDISCREEN II NEGATIVE CONTROL AND SOLIDCREEN II CONTROL - ALSO USED BY THE CUSTOMER - WAS TESTED. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS. BASED ON THE ONGOING INVESTIGATION WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT. UNTIL NOW, THE COMPLAINT SAMPLES WERE NOT PROVIDED FOR INVESTIGATION AND THE RETENTION SAMPLE REACTED AS EXPECTED. THE ANALYSIS OF THE INSTRUMENT DATA IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751250 ↗
• MalfunctionJul 16, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT THEIR BIOTESTCELL I-11 PLUS PANEL YIELDED NEGATIVE REACTIONS ON TANGO INFINITY. THE CUSTOMER ANNOUNCED TO PROVIDE A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I-11 PLUS FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITHIN THE SHELF-LIFE. THE RETENTION SAMPLE WAS TESTED WITH THREE KNOWN ANTIBODIES (ANTI-K, ANTI-FYA AND ANTI-C). ALL REAGENT RED BLOOD CELLS SHOWED CLEARLY POSITIVE REACTIONS WITH THE CORRESPONDING ANTIBODY. FURTHERMORE, SOLDISCREEN II NEGATIVE CONTROL AND SOLIDCREEN II CONTROL ALSO USED BY THE CUSTOMER - WERE TESTED. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS. THE CUSTOMER PROVIDED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL-I11 PLUS, AHG ANTI-IGG SC II AND A PATIENT SAMPLE (NO. 169) FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THE AHG ANTI-IGG SCII THAT WAS PROVIDED BY THE CUSTOMER AND A CURRENT LOT OF BIOTESTCELL-I11 PLUS (LOT 9426011-00), BECAUSE THE COMPLAINT SAMPLE WAS ALREADY EXPIRED UPON ARRIVAL. AGAIN THRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750361 ↗
• MalfunctionJul 16, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT THEIR BIOTESTCELL I-11 PLUS PANEL YIELDING NEGATIVE REACTIONS ON TANGO INFINITY.THE CUSTOMER ANNOUNCED TO PROVIDE A PRODUCT SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL I-11 PLUS FOR INVESTIGATIONAL TESTING. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITHIN THE SHELF-LIFE. THE RETENTION SAMPLE WAS TESTED WITH THREE KNOWN ANTIBODIES (ANTI-K, ANTI-FYA AND ANTI-C). ALL REACTIONS OF THE REAGENT RED BLOOD CELLS SHOWED CLEARLY POSITIVE REACTIONS WITH THE CORRESPONDING ANTIBODY. FURTHERMORE, SOLDISCREEN II NEGATIVE CONTROL AND SOLIDCREEN II CONTROL - ALSO USED BY THE CUSTOMER - WAS TESTED. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED CORRECT RESULTS. WE DID NOT OBSERVE FALSE NEGATIVE REACTIONS. BASED ON THE ONGOING INVESTIGATION WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT. UNTIL NOW, THE COMPLAINT SAMPLES WERE NOT PROVIDED FOR INVESTIGATION AND THE RETENTION SAMPLE REACTED AS EXPECTED. THE ANALYSIS OF THE INSTRUMENT DATA IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749974 ↗
• MalfunctionApr 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION WITH CELL NO.4 (DONOR NO. (B)(6)) OF BIOTESTCELL-I11 PLUS WITH THE ANTI-M REAGENT OF THE COMPETITOR GRIFOLS. THE CUSTOMER ANNOUNCED TO SHIP THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TESTED CELL NO. 4 (DONOR (B)(6)) WITH SERACLONE ANTI-M, SERACLONE ANTI-N, SERACLONE ANTI-S AND SERACLONE ANTI-S AND CONFIRMED THE REACTION PATTERN OF THE ANTIGEN TABLE OF DONOR 990015 REGARDING THE MNS SYSTEM: NNSS. WE DID NOT OBSERVE ANY POSITIVE REACTION WITH SERACLONE ANTI-M. ADDITIONALLY, CELL NO. 4 (DONOR (B)(6)) WAS TESTED WITH A POLYCLONAL ANTI-M. AGAIN, THE REACTION WAS CLEARLY NEGATIVE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161524 ↗
• MalfunctionMay 30, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT CELL #10 OF BIOTESTCELL-I11 PLUS (DONOR (B)(6)) SHOWED A FALSE NEGATIVE REACTION WITH ANTI-KPB. ACCORDING TO THE ANTIGEN TABLE DONOR (B)(6) IS KPA-B+. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE BIOTESTCELL-I11 PLUS FOR INVESTIGATIONAL TESTING NOR THE REAGENT THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL-I11 PLUS OF THE SUPPOSEDLY DEFECTIVE LOT WITH THREE DIFFERENT ANTI-KPB. THE USED ANTI-KPB WERE: ANTI-KPB LOT 2038020-00 (FINISHED PRODUCT), ANTI-KPB (HIGH FREQUENT PLASMA) AND ID-ANTIGEN PROFILE II. CELL #10 OF BIOTESTCELL-I11 PLUS SHOWED CLEARLY POSITIVE REACTIONS WITH ALL THREE ANTISERA. BASED ON OUR INVESTIGATION WE COULD NOT CONFIRM THE CUSTOMER'S FINDING. A MISTYPING IN THE ANTIGEN TABLE COULD BE EXCLUDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539265 ↗
• MalfunctionAug 23, 2018False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT SAMPLE WHEN TESTED WITH BIOTESTCELL-I11 PLUS ON TANGO INFINITY. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE KNOWN ANTIBODY IS ANTI-D DUE TO THE RH(D) PROPHYLAXIS. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE TEST RESULT. TESTING OF OUR RETAINED PRODUCT SAMPLE IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF BOTH ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY HAS BEEN INSPECTED BY OUR FIELD SERVICE ENGINEERS AND FOUND TO BE WORKING WITHIN SPECIFICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808413 ↗
• MalfunctionJun 19, 2018False Negative Result; Defective Component

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE ANTIBODY SCREENING RESULTS FOR ANTI-JKA USING BIOTESTCELL -I 11 PLUS 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 PLUS LOT #8815011-00. 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 PLUS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 PLUS 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 WER

  Patient problems: No Information

  MAUDE report 7613013 ↗
• MalfunctionJun 19, 2018False Negative Result

  THE CUSTOMER RAN AN ANTIBODY SCREEN ON A NEW PATIENT SAMPLE ON THE TANGO INFINITY S/N (B)(4) WITH BIOTESTCELL 3 LOT #8815021-00. THE ANTIBODY SCREEN WAS NEGATIVE. THE SAMPLE WAS PERFORMED ON THE IMMUCOR ECHO BUT THE ANTIBODY SCREEN WAS 3+ POSITIVE. THE CUSTOMER RAN THE SAME SAMPLE ON A DIFFERENT TANGO INFINITY, S/N (B)(4) AND THE ANTIBODY SCREEN WAS WEAKLY POSITIVE ON CELL #2 OF THE BIOTESTCELL-3. AN ANTIBODY PANEL WAS PERFORMED ON TANGO INFINITY, S/N (B)(4) WITH BIOTESTCELL-I 11 PLUS, LOT #8815011-00. THE ANTIBODY PANEL WAS POSITIVE ON CELL #5 ONLY. THE ANTIBODY SCREEN AND PANEL PERFORMED ON THE IMMUCOR ECHO DEMONSTRATED AN ANTI-JKA ANTIBODY 3+ POSITIVE. THE CUSTOMER DID NEITHER PROVIDE THE PATIENT SAMPLES HAD CAUSED DISCREPANT RESULTS FOR INVESTIGATIONAL TESTING NOR THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 PLUS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL-I11 PLUS 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

  Patient problems: No Information

  MAUDE report 7613006 ↗
• MalfunctionJan 11, 2018Device Expiration Issue; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WHEN TESTED USING BIOTESTCELL-I11 PLUS ON TANGO INFINITY. THE SPECIFICITY OF THE MISSED ANTIBODY IS ANTI-JK(B). THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE SUPPOSEDLY DEFECTIVE PRODUCT THE LOT WAS ALREADY EXPIRED. OUR QUALITY CONTROL LABORATORY IS STILL TESTING THE SOLID SCREEN II REAGENTS AND THE PATIENT SAMPLE PROVIDED BY CUSTOMER. WITHIN ITS SHELF LIFE THE RETENTION SAMPLE OF BIOTESTCELL-I11 PLUS WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-JK(B). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181476 ↗
• MalfunctionNov 28, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH AN ANTI-E WHEN TESTED WITH BIOTESTCELL-I11 PLUS ON TANGO INFINITY. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-E FROM A PROFICIENCY TESTING. 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 BIOTESTCELL-I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. NO INDICATION FOR AN INSTRUMENT MALFUNCTION COULD BE IDENTIFIED. THE SERVICE ENGINEER CONFIRMED A PROPER FUNCTION OF THE INSTRUMENT BY METROLOGY QUALIFICATION. THE SSC II QC WAS RUN WITHOUT ANY COMPLAINT RELEVANT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062968 ↗
• MalfunctionNov 16, 2017False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH A KNOWN ANTI-D WITH CELL #4 OF BIOTEST CELL-I11 PLUS ON TANGO OPTIMO. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL-I11 PLUS, BUT ONLY THE AFFECTED CELL #4 AND NOT THE COMPLETE PANEL. THE CUSTOMER ALSO RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE MATERIAL PROVIDED BY CUSTOMER THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT SAMPLE ON TANGO OPTIMO AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED WITH THE CURRENT LOT OF BIOTEST CELL-I11 PLUS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RETENTION SAMPLE OF THE COMPLAINED LOT WAS TESTED DURING ITS SHELF LIFE WITH DIFFERENT SAMPLES AND CONTROLS E.G. ANTI-D. AGAIN, ALL RESULTS WERE AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL-I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036870 ↗
• MalfunctionNov 16, 2017False Negative Result; Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH A KNOWN ANTI-D WITH CELL #4 OF BIOTEST CELL-I11 PLUS ON TANGO OPTIMO. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL-I11 PLUS, BUT ONLY THE AFFECTED CELL #4 AND NOT THE COMPLETE PANEL. THE CUSTOMER ALSO RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE MATERIAL PROVIDED BY CUSTOMER THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT SAMPLE ON TANGO OPTIMO AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY THE PATIENT SAMPLE WAS TESTED WITH THE CURRENT LOT OF BIOTEST CELL-I11 PLUS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RETENTION SAMPLE OF THE COMPLAINED LOT WAS TESTED DURING ITS SHELF LIFE WITH DIFFERENT SAMPLES AND CONTROLS E.G. ANTI-D. AGAIN, ALL RESULTS WERE AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL-I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036865 ↗
• MalfunctionNov 16, 2017False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH A KNOWN ANTI-JK(A) WHEN TESTED WITH BIOTEST CELL-I11 PLUS ON TANGO INFINITY. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO ALIQUOTS OF TWO PATIENT SAMPLES LABELLED PATIENT A AND PATIENT B. ACCORDING TO THE CUSTOMER'S DOCUMENTATION THE ALIQUOTS OF PATIENT A CONTAINED AN ANTI-JK(A) AND THE ONES OF PATIENT B AN ANTI-E. BECAUSE ONLY VERY LITTLE MATERIAL SENT FROM PATIENT B WAS AVAILABLE, OUR QUALITY CONTROL LABORATORY COULD ONLY TEST PATIENT SAMPLE A WITH THE RETURNED COMPLAINT SAMPLE OF BIOTEST CELL-I11 PLUS ON TANGO INFINITY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY THE COMPLAINT SAMPLE WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-E AND ANTI-JK(A) FROM AN INTERLABORATORY COMPARISON TEST. AGAIN, ALL RESULTS WERE AS EXPECTED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL-I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY D

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036307 ↗
• MalfunctionAug 11, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH ANTI-D SHOWED A WEAK OR NO REACTIVITY WITH CELL #4 OF BIOTEST CELL-I11 PLUS DURING MANUAL TUBE TESTING. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE ALLEGEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLE NOR THE SUPPOSEDLY DEFECTIVE PRODUCT THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. INVESTIGATIONAL TESTING OF THIS COMPLAINT WAS NOT POSSIBLE BECAUSE THE ALLEGEDLY DEFECTIVE MATERIAL WAS NOT AVAILABLE AND THE CASE WAS REPORTED AFTER THE PRODUCT HAD EXPIRED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787434 ↗
• MalfunctionAug 11, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH ANTI-D SHOWED A FALSE NEGATIVE REACTION WITH CELL #4 OF BIOTESTCELL-I11 PLUS. THIS HAPPED DURING MANUAL TUBE TESTING. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE ALLEGEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THE CUSTOMER HAS NOT RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT AND ALSO NOT THE EXPIRED PRODUCT. INVESTIGATIONAL TESTING OF THIS COMPLAINT WAS NOT POSSIBLE BECAUSE THE ALLEGEDLY DEFECTIVE MATERIAL WAS NOT AVAILABLE AND THE CASE WAS REPORTED AFTER THE PRODUCT HAD ALREADY EXPIRED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787427 ↗
• MalfunctionJul 13, 2017False Negative Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH ANTI-D SHOWED A FALSE NEGATIVE REACTION WITH CELL #4 OF BIOTEST CELL-I11 PLUS. THE CUSTOMER PERFORMED THE MANUAL TUBE TESTING WITH THE ENHANCEMENT OF POLYETHYLENE GLYCOL (PEG). THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. THE CUSTOMER RETURNED THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE IN PARALLEL TO THE RETENTION SAMPLE WITH DIFFERENT SAMPLES AND CONTROLS INCLUDING ANTI-D. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE DEFECTIVE LOT OF BIOTEST CELL-11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6709794 ↗
• MalfunctionJun 7, 2017False Negative Result

  THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE WITH AN ANTI-JK(A) SHOWED FALSE NEGATIVE REACTIONS WITH BIOTEST CELL-I11 PLUS WHEN TESTED ON TANGO INFINITY. THE CUSTOMER REPORTED THAT THE ANTI-E OF THE AFFECTED SAMPLE WAS CORRECTLY DETECTED. SHE STATED THAT DURING VALIDATION ANTIBODIES OF OVERALL FOUR SAMPLES WERE NOT DETECTED ON TANGO INFINITY. THE SPECIFICITIES OF THE MISSED ANTIBODIES WERE ANTI-JK(A) AND ANTI-FY(A). THE CUSTOMER RETURNED ONE SAMPLE THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTEST CELL-I11 PLUS. THE SPECIFICITY OF THE SUBMITTED SAMPLE WAS ANTI-FY(A). OUR QUALITY CONTROL LABORATORY TESTED THIS SPECIMEN WITH THE SAMPLE OF BIOTEST CELL-I11 PLUS RETURNED BY THE CUSTOMER ON TANGO INFINITY. THE ANTI-FY(A) WAS CLEARLY DETECTED. THE COMPLAINT SAMPLE WAS ALSO TESTED WITH DIFFERENT SAMPLES AND CONTROLS ON TANGO INFINITY, E.G. AN ANTI-E, ANTI-JK(A) AND ANTI-FY(A). 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-11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6617153 ↗
• MalfunctionSep 21, 2016Incorrect Or Inadequate Test Results; Defective Device

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH AN ANTI-S SHOWED A FALSE NEGATIVE REACTION WHEN TESTED WITH CELL #7 OF BIOTESTCELL-I11 PLUS IN THE TUBE TECHNIQUE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT AND ALSO THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG REAGENT, BUT NOT THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. AT THE TIME WE RECEIVED THE SUPPOSEDLY DEFECTIVE PRODUCT, THE AFFECTED LOT BIOTESTCELL-I11 PLUS WAS ALREADY EXPIRED. NEVERTHELESS THE RETURNED PRODUCT'S SAMPLE CELL #7 OF BIOTESTCELL-I11 PLUS WAS TESTED WITH SERACLONE ANTI-S AND SERACLONE ANTI-S. CELL #7 SHOWED A CLEARLY POSITIVE REACTION WITH SERACLONE ANTI-S AND A NEGATIVE REACTION WITH SERACLONE ANTI-S. THESE REACTIONS CORRESPOND TO THE ANTIBODY IDENTIFICATION TABLE AND THE RESULTS OF THE INCOMING GOOD INSPECTION AS WELL AS THE RESULTS OF THE DONATION CENTER THAT PROVIDED THE DONOR UNIT FOR CELL #7. THE CORRECT FUNCTION OF THE AHG ANTI-IGG SUBMITTED BY CUSTOMER WAS ALSO VERIFIED. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 PLUS FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5965630 ↗