Biotestcell® A2 816047100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611969952625), received between Apr 30, 2019 and Apr 23, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF BIOTESTCELL-A2 WITH ANTI-A1. THE CUSTOMER USED AN ANTI-A1 LECTIN FROM A COMPETITOR AND STATED THAT THE REACTION WAS 1+ POSITIVE INSTEAD OF NEGATIVE. THE CUSTOMER ANNOUNCED TO SHIP A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH SERACLONE ANTI-A1. THE REACTION WAS CORRECTLY NEGATIVE. ADDITIONALLY, BIOTESTCELL-A2 WAS TESTED WITH DIFFERENT DONOR SAMPLES ACCORDING TO THE INSTRUCTION FOR USE. 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 WE RECEIVED THE PRODUCT SAMPLE OF BIOTESTCELL-A2 RETURNED BY THE CUSTOMER, IT HAD EXPIRED AND WAS THEREFORE NOT TESTED. ADDITIONALLY THE CUSTOMER HAD RETURNED A ALIQUOT OF THE ANTI-A1 LECTIN. TOGETHER WITH THE ANTI-A1 LECTIN, THE CUSTOMER HAD MISTAKENLY SENT THE PREVIOUS LOT OF BIOTESTCELL-A2 (LOT 9406011-00, EXP. DATE 2024-08-04) ALTHOUGH SHE HAD NOT FILED A COMPLAINT FOR THIS LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161630 ↗
• MalfunctionJul 13, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED WEAK POSITIVE TO FALSE NEGATIVE REACTIONS WITH BIOTESTCELL-A2 WHEN THEY WERE EXPECTED TO BE CLEARLY POSITIVE. THE CUSTOMER STATED THAT SHE OBSERVED THIS ISSUE WHEN PERFORMING MANUAL QC WITH IMMUCOR CORE QC KIT. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE BIOTESTCELL-A2 FOR INVESTIGATIONAL TESTING. THEREFORE; OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESPECTIVELY WEAKENED REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE COMPLAINT INVESTIGATION SHOWED THAT THE CUSTOMER DID NOT USE THE CORRECT IFU AND DID NOT REALIZE THE STATEMENT UNDER THE TEST PROCEDURE TO INCUBATE FOR 15 TO 30 MINUTES IF NECESSARY. THE CUSTOMER INCUBATED FOR AN ADDITIONAL 15 MINUTES AND THE REACTION CAME UP AS 2+ POSITIVE. THE CUSTOMER INFORMED US THAT SHE RECEIVED THE CORRECT RESULTS AFTER FOLLOWING THE INSTRUCTION FOR USE AND INCUBATING THE TEST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998514 ↗
• MalfunctionJul 13, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED WEAK POSITIVE TO FALSE NEGATIVE REACTIONS WITH BIOTESTCELL-A2 WHEN THEY WERE EXPECTED TO BE CLEARLY POSITIVE. THE CUSTOMER STATED THAT SHE OBSERVED THIS ISSUE WHEN PERFORMING MANUAL QC WITH IMMUCOR CORE QC KIT. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE BIOTESTCELL-A2 FOR INVESTIGATIONAL TESTING. THEREFORE; OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESPECTIVELY WEAKENED REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE COMPLAINT INVESTIGATION SHOWED THAT THE CUSTOMER DID NOT USE THE CORRECT IFU AND DID NOT REALIZE THE STATEMENT UNDER THE TEST PROCEDURE TO INCUBATE FOR 15 TO 30 MINUTES IF NECESSARY. THE CUSTOMER INCUBATED FOR AN ADDITIONAL 15 MINUTES AND THE REACTION CAME UP AS 2+ POSITIVE. THE CUSTOMER INFORMED US THAT SHE RECEIVED THE CORRECT RESULTS AFTER FOLLOWING THE INSTRUCTION FOR USE AND INCUBATING THE TEST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998511 ↗
• MalfunctionMar 23, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF BIOTESTCELL-A2 DURING MANUAL TESTING. SHE STATED THAT A PATIENT SAMPLE WITH A KNOWN COLD AGGLUTININ AND THE HEMOBIOSCIENCE CONTROL QC1 (BLOOD GROUP A RH NEGATIVE, NO ANTIBODIES) SHOWED THE FALSE POSITIVE REACTIONS. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE BIOTESTCELL-A2 FOR INVESTIGATIONAL TESTING NOR THE SPECIMENS THAT HAD CAUSED THE FALSE POSITIVE TEST RESULTS. WHEN THE CUSTOMER ANNOUNCED THAT SHE WOLD PROVIDE HER COMPLAINT SAMPLE AND THE QC AFTER ALL, BOTH HAD ALREADY EXPIRED. THEREFORE, WE DID NOT REQUEST THEM ANY LONGER. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES. THE TESTING WAS PERFORMED MANUALLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE TESTS WERE PERFORMED AS IMMEDIATE SPIN TEST AND WITH AN INCUBATION FOR 30 MINUTES AT ROOM TEMPERATURE. IN ALL CASES THE POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED. THE COMPLAINT SAMPLE WAS NOT AVAILABLE, AND THE RETENTION SAMPLE REACTED AS EXPECTED. BECAUSE NEITHER THE COMPLAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13867914 ↗
• MalfunctionSep 2, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT BIOTESTCELL A2 SHOWED A FALSE POSITIVE RESULT WITH THE ANTI-A1 LECTIN FROM IMMUCOR AND HE HAD ALREADY OBSERVED THIS PROBLEM WITH THE PREVIOUS LOT. THE CUSTOMER PROVIDED BOTH AFFECTED LOTS BIOTESTCELL-A2 AND TWO DIFFERENT LOTS ANTI-A1 FROM IMMUCOR FOR INVESTIGATIONAL TESTING. BIOTESTECELL-A2 (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) WAS TESTED WITH SERACLONE ANTI-A, SERACLONE ANTI-B, SERACLONE ANTI-A,B, SERACLONE ANTI-A1 AND SERACLONE ANTI-H. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT: BIOTESTCELL-A2 (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) SHOWED POSITIVE REACTIONS WITH SERACLONE ANTI-A, SERACLONE ANTI-A, B AND SERACLONE ANTI-H AND NEGATIVE REACTIONS WITH SERACLONE ANTI-B AND SERACLONE ANTI-A1. ADDITIONALLY, BIOTESTCELL-A2 (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) WAS TESTED WITH DIFFERENT DONOR SAMPLES OF BLOOD GROUP A1, A2, B AND O. AGAIN, ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. FURTHERMORE BIOTESTCELL-A2 (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) WAS TESTED WITH ANTI-A1 LECTIN AND SHOWED WEAK POSITIVE REACTIONS. BIOTESTCELL A2 (COMPLAINT SAMPLE, RETENTION SAMPLE AND REFERENCE LOT) WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412589 ↗
• MalfunctionApr 30, 2019False Positive Result; Defective Device

  THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF BIOTESTCELL-A2 WITH THE ANTI-A1 LECTIN REAGENT OF A COMPETITOR. THE CUSTOMER PROVIDED THE COMPLAINT PRODUCT SAMPLE, BUT NOT THE ANTI-A1 REAGENT USED IN THIS TESTING. AT THE TIME WE RECEIVED THE COMPLAINT SAMPLE ON OUR PREMISES, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. WITHIN ITS SHELF LIFE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL A2 WITH THE ANTI-A1 LECTIN REAGENT AND COULD CONFIRM CUSTOMER´S FINDING: THE SUPPOSEDLY DEFECTIVE PRODUCT YIELDED A WEAK FALSE POSITIVE REACTION. ADDITIONALLY BIOTESTCELL-A2 WAS TESTED WITH SERACLONE ANTI-A1 AND YIELDED A CORRECTLY NEGATIVE REACTION. THE WEAK FALSE POSITIVE REACTION WAS ONLY OBSERVED WITH THE ANTI-A1 LECTIN REAGENT OF A COMPETITOR. BASED ON THIS FALSE POSITIVE REACTION WE INITIATED FURTHER ACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563628 ↗
• MalfunctionApr 30, 2019False Positive Result; Defective Device

  THE CUSTOMER REPORTED A WEAK FALSE POSITIVE REACTION OF BIOTESTCELL-A2 WITH THE ANTI-A1 LECTIN REAGENT OF A COMPETITOR. THE CUSTOMER PROVIDED A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT BIOTESTCELL-A2 FOR INVESTIGATIONAL TESTING AND ALSO THE ANTI-A1 REAGENT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE AS WELL AS THEIR RETENTION SAMPLE OF BIOTESTCELL A2 WITH THE ANTI-A1 LECTIN REAGENT AND COULD CONFIRM THE CUSTOMER´S FINDING: THE SUPPOSEDLY DEFECTIVE PRODUCT YIELDED A WEAK FALSE POSITIVE REACTION. ADDITIONALLY THE COMPLAINT AND THE RETENTION SAMPLE OF BIOTESTCELL-A2 WERE TESTED WITH SERACLONE ANTI-A1 AND YIELDED CORRECTLY NEGATIVE REACTIONS. THE WEAK FALSE POSITIVE REACTIONS WERE ONLY OBSERVED WITH THE ANTI-A1 LECTIN REAGENT OF A COMPETITOR. BASED ON THIS FALSE POSITIVE REACTION WE INITIATED FURTHER ACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563627 ↗