Biotestcell® A1 & B 816057100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969952663), received between Apr 16, 2020 and May 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS OF PATIENT SAMPLES WITH BIOTESTCELL A1&B IN THE REVERSE TYPING. THE CUSTOMER STATED THAT SHE A PATIENT SAMPLE WITH AN ANTI-M CAUSED INTERFERENCES WITH BIOTESTCELL A1&B. FURTHERMORE, THE CUSTOMER STATED THAT THE REVERSE TYPING REAGENT RED BLOOD CELLS OF ORTHO WOULD BE M ANTIGEN NEGATIVE. THE DUSTOMER DID NOT PROVIDE A DATE OF EVENT. THE CUSTOMER DID NEITHER RETURN A PRODUCT SAMPLE OF BIOTESTCELL A1&B, LOT 9402011-00 FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT SHOWED INTERFERENCES. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF THE CURRENT LOTS OF BIOTESTCELL A1&B: LOT 9402011-00 (LOT THE CUSTOMER FILED HER COMPLAINT FOR), LOT 9406011-00 AND LOT 9410011-00 WITH DIFFERENT DONOR SAMPLES ACCORDING TO THE INSTRUCTION FOR USE (IFU). ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. WITHIN THE PRODUCTION PROCESS BIOTESTCELL A1&B WAS TESTED FOR THE ABO BLOODGROUPS, THE RH PHENOTYPES AND THE ANTIGENS KELL (KEL1) AND CELLANO (KEL2) ACCORDING TO THE REQUIREMENTS. THE ACCEPTANCE CRITERIA WERE MET. TESTING FOR FURTHER ANTIGENS WAS NOT MANDATORY. BASED ON THE INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357772 ↗
• MalfunctionApr 16, 2020False Positive Result

  THE CUSTOMER REPORTED ISSUES WITH BIOTESTCELL A1&B. THE CUSTOMER STATED THAT THERE ARE PATIENTS THAT GENERATED WHAT SHE DESCRIBED AS ROULEAUX FORMATION IN THE REVERSE TYPING. THE CUSTOMER STATED THAT SHE SAW THE EXTRA REACTION (FALSE POSITIVE) REACTION WITH BIOTESTCELL A1. FURTHERMORE SHE REPORTED THAT THEY USED SUCCESSFULLY A SALINE REPLACEMENT ACCORDING TO THE AABB TECHNICAL MANUAL TO RESOLVE UNEXPECTED POSITIVE REACTIONS. THE EXACT DATE OF EVENT IS NOT KNOWN. THE CUSTOMER HAS NOT RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL A1&B FOR INVESTIGATIONAL TESTING BUT WILL PROVIDE TWO PATIENT SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS. IN THE MEAN TIME OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES IN THE TUBE TECHNIQUE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION RESPECTIVELY ROULEAUX FORMATION. ADDITIONALLY THE BLOOD GROUP A RESPECTIVELY B OF THE RETENTION SAMPLE WAS CONFIRMED WITH THE BLOOD GROUPING REAGENTS SERACLONE ANTI-A, SERACLONE ANTI-B, SERACLONE ANTI-AB, SERACLONE ANTI-A1 AND SERACLONE ANTI-H. AGAIN, ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. A REVIEW OF TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966960 ↗