BIOCLONE 711320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10758750003075), received between Feb 17, 2023 and Dec 27, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  REPORT 5 OF 5 CMS (B)(4), WINDCHILL RA608466 ON (B)(6)2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT WEAK TO 1+ POSITIVE RESULTS FOR FIVE PATIENT SAMPLES WITH ANTI-B (ANTI-ABO2) BIOCLONE, LOT BBB826A, IN MANUAL TUBE METHOD BETWEEN (B)(6)2024. COMPLAINANT: (B)(6); BLOOD BANK SUPERVISOR (B)(6); (B)(6) CUSTOMER# (B)(6); (B)(6) HOSPITAL (B)(6) DATE OF EVENTS: 17NOV2024, 30NOV2024 AND 01DEC2024 (REPORTED 02DEC2024) REAGENT: ANTI-B (ANTI-ABO2) BIOCLONE (MURINE MONOCLONAL BLEND) LOT BBB826A, EXPIRY 09JAN2026, MANUFACTURED 09JAN2024 PATIENT INFORMATION: 5 PATIENT SAMPLES AFFECTED. NO FURTHER DETAILS PROVIDED. THE CUSTOMER REPORTED THAT BEGINNING (B)(6)2024, THEY HAD TESTED FIVE PATIENT SAMPLES FOR ABO FORWARD TYPING USING ANTI-B BIOCLONE IN MANUAL TUBE METHOD AND THAT UNEXPECTED WEAK POSITIVE TO 1+ REACTIONS WERE OBTAINED. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE ON (B)(6)2024 WAS RETESTED WITH THE SAME LOT OF ANTI-B BIOCLONE REAGENT FOLLOWING A WARM WASH OF THE PATIENT CELLS AND THE RESULT WAS NEGATIVE, AS EXPECTED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6)2024, FOUR ADDITIONAL SAMPLES REPORTED WEAK TO 1+ RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030248 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  REPORT 4 OF 5 CMS (B)(4), WINDCHILL RA608466 ON (B)(6)2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT WEAK TO 1+ POSITIVE RESULTS FOR FIVE PATIENT SAMPLES WITH ANTI-B (ANTI-ABO2) BIOCLONE, LOT BBB826A, IN MANUAL TUBE METHOD BETWEEN 17NOV2024 AND 01DEC2024. COMPLAINANT: (B)(6); BLOOD BANK SUPERVISOR (B)(6) CUSTOMER# (B)(6); (B)(6) HOSPITAL (B)(6) DATE OF EVENTS: 17NOV2024, 30NOV2024 AND 01DEC2024 (REPORTED (B)(6)2024) REAGENT: ANTI-B (ANTI-ABO2) BIOCLONE (MURINE MONOCLONAL BLEND) LOT BBB826A, EXPIRY 09JAN2026, MANUFACTURED 09JAN2024 PATIENT INFORMATION: 5 PATIENT SAMPLES AFFECTED. NO FURTHER DETAILS PROVIDED. THE CUSTOMER REPORTED THAT BEGINNING (B)(6)2024, THEY HAD TESTED FIVE PATIENT SAMPLES FOR ABO FORWARD TYPING USING ANTI-B BIOCLONE IN MANUAL TUBE METHOD AND THAT UNEXPECTED WEAK POSITIVE TO 1+ REACTIONS WERE OBTAINED. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE ON (B)(6) 2024 WAS RETESTED WITH THE SAME LOT OF ANTI-B BIOCLONE REAGENT FOLLOWING A WARM WASH OF THE PATIENT CELLS AND THE RESULT WAS NEGATIVE, AS EXPECTED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6)2024, FOUR ADDITIONAL SAMPLES REPORTED WEAK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030122 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  REPORT 3 OF 5 (B)(4), WINDCHILL (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT WEAK TO 1+ POSITIVE RESULTS FOR FIVE PATIENT SAMPLES WITH ANTI-B (ANTI-ABO2) BIOCLONE, LOT BBB826A, IN MANUAL TUBE METHOD BETWEEN (B)(6) 2024 AND (B)(6) 2024. COMPLAINANT: (B)(6); BLOOD BANK SUPERVISOR +(B)(6). DATE OF EVENTS: 17NOV2024, (B)(6) 2024 AND (B)(6) 2024 (REPORTED 02DEC2024) REAGENT: ANTI-B (ANTI-ABO2) BIOCLONE (MURINE MONOCLONAL BLEND) LOT BBB826A, EXPIRY 09JAN2026, MANUFACTURED 09JAN2024. PATIENT INFORMATION: 5 PATIENT SAMPLES AFFECTED. NO FURTHER DETAILS PROVIDED. THE CUSTOMER REPORTED THAT BEGINNING (B)(6) 2024 THROUGH (B)(6) 2024, THEY HAD TESTED FIVE PATIENT SAMPLES FOR ABO FORWARD TYPING USING ANTI-B BIOCLONE IN MANUAL TUBE METHOD AND THAT UNEXPECTED WEAK POSITIVE TO 1+ REACTIONS WERE OBTAINED. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE ON (B)(6) 2024 WAS RETESTED WITH THE SAME LOT OF ANTI-B BIOCLONE REAGENT FOLLOWING A WARM WASH OF THE PATIENT CELLS AND THE RESULT WAS NEGATIVE, AS EXPECTED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6) 2024 AND (B)(6) 2024, FOUR ADDITIONAL SAMPLES REPORTED WEAK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029972 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  REPORT 2 OF 5 (B)(4), WINDCHILL (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT WEAK TO 1+ POSITIVE RESULTS FOR FIVE PATIENT SAMPLES WITH ANTI-B (ANTI-ABO2) BIOCLONE, LOT BBB826A, IN MANUAL TUBE METHOD BETWEEN (B)(6) 2024 AND (B)(6) 2024. COMPLAINANT: (B)(6); BLOOD BANK SUPERVISOR (B)(6). DATE OF EVENTS: 17NOV2024, (B)(6) 2024 AND (B)(6) 2024 (REPORTED 02DEC2024) REAGENT: ANTI-B (ANTI-ABO2) BIOCLONE (MURINE MONOCLONAL BLEND) LOT BBB826A, EXPIRY 09JAN2026, MANUFACTURED 09JAN2024 PATIENT INFORMATION: 5 PATIENT SAMPLES AFFECTED. NO FURTHER DETAILS PROVIDED. THE CUSTOMER REPORTED THAT BEGINNING (B)(6) 2024 THROUGH (B)(6) 2024, THEY HAD TESTED FIVE PATIENT SAMPLES FOR ABO FORWARD TYPING USING ANTI-B BIOCLONE IN MANUAL TUBE METHOD AND THAT UNEXPECTED WEAK POSITIVE TO 1+ REACTIONS WERE OBTAINED. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE ON (B)(6) 2024 WAS RETESTED WITH THE SAME LOT OF ANTI-B BIOCLONE REAGENT FOLLOWING A WARM WASH OF THE PATIENT CELLS AND THE RESULT WAS NEGATIVE, AS EXPECTED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6) 2024 AND (B)(6) 2024, FOUR ADDITIONAL SAMPLES REPORTED WEAK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029700 ↗
• MalfunctionDec 27, 2024False Positive Result; False Positive Result

  REPORT 1 OF 5 (B)(4), WINDCHILL (B)(4) ON (B)(6)2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT WEAK TO 1+ POSITIVE RESULTS FOR FIVE PATIENT SAMPLES WITH ANTI-B (ANTI-ABO2) BIOCLONE, LOT BBB826A, IN MANUAL TUBE METHOD BETWEEN (B)(6)2024. (B)(6); THE (B)(6) HOSPITAL (B)(6) DATE OF EVENTS: 17NOV2024, 30NOV2024 AND 01DEC2024 (REPORTED 02DEC2024) REAGENT: ANTI-B (ANTI-ABO2) BIOCLONE (MURINE MONOCLONAL BLEND) LOT BBB826A, EXPIRY 09JAN2026, MANUFACTURED 09JAN2024 PATIENT INFORMATION: 5 PATIENT SAMPLES AFFECTED. NO FURTHER DETAILS PROVIDED. THE CUSTOMER REPORTED THAT BEGINNING (B)(6)2024, THEY HAD TESTED FIVE PATIENT SAMPLES FOR ABO FORWARD TYPING USING ANTI-B BIOCLONE IN MANUAL TUBE METHOD AND THAT UNEXPECTED WEAK POSITIVE TO 1+ REACTIONS WERE OBTAINED. THE CUSTOMER REPORTED THAT THE AFFECTED SAMPLE ON (B)(6)2024 WAS RETESTED WITH THE SAME LOT OF ANTI-B BIOCLONE REAGENT FOLLOWING A WARM WASH OF THE PATIENT CELLS AND THE RESULT WAS NEGATIVE, AS EXPECTED. THE CUSTOMER REPORTED THAT BETWEEN (B)(6)2024, FOUR ADDITIONAL SAMPLES REPORTED WEAK TO 1+ REACTIVITY WITH ANTI-B BIOCLONE LOT BBB826A. THE CUSTOMER STATED THAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029647 ↗
• MalfunctionMar 22, 2023False Negative Result; False Negative Result

  (B)(4) DISCREPANT B(ABO2) ANTIGEN TYPING REACTIONS FOR ONE PATIENT IDENTIFIED DURING A LITERATURE REVIEW. THE PATIENT SHOWED TYPICAL A(ABO1) BLOOD TYPE CHARACTERISTICS DUE TO A POSITIVE (3+) REACTION OBTAINED WITH THE REVERSE B(ABO2) CELLS, SUGGESTING THIS PATIENT HAS ANTI-B(ABO2) ANTIBODIES AS IF THEY WERE TYPICAL A(ABO1) BLOOD GROUP. THE ASSIGNABLE CAUSE IS SAMPLE RELATED, THE PATIENT HAVING A WEAK EXPRESSION OF THE B(ABO2) ANTIGEN WITHIN THEIR CIS-AB BLOOD GROUP. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591963 ↗
• MalfunctionFeb 17, 2023False Positive Result; False Positive Result

  MXP32199598; RA601037 A CUSTOMER COMPLAINED TO THE ORTHOCARE HELPDESK ON (B)(6) 2023 AFTER OBTAINING DISCREPANT POSITIVE B(ABO2) ANTIGEN TYPING RESULTS FOR ONE PATIENT USING ORTHO BIOCLONE ANTI-B LOT BBB821AX IN MANUAL SLIDE METHOD. COMPLAINANT/COMPLAINT REPORTER: (B)(6) DATE OF EVENT: (B)(6) 2023 REPORTED ON: (B)(6) 2023 BY (B)(6) TO THE ORTHOCARE HELPDESK REAGENTS: ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE FOR SLIDE, TUBE AND MICROPLATE TESTS LOT BBB821AX EXPIRY DATE 31 MAY 2024 MANUFACTURE DATE 31 MAY 2022 PATIENT INFORMATION: NO TRANSFUSION HISTORY; NEW PATIENT THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY HAD TESTED A PATIENT SAMPLE FOR ABO FORWARD TYPING USING ORTHO BIOCLONE ANTI-B LOT BBB821AX IN MANUAL SLIDE METHOD AND THAT THEY HAD OBTAINED A POSITIVE REACTION WITH THE ANTI-B REAGENT. THE CUSTOMER REPORTED THAT THE ORTHO MANUAL SLIDE METHOD FOR ABO FORWARD GAVE A RESULT OF AB D(RH1) POSITIVE. NO FURTHER DETAIL PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY HAD RETESTED THIS PATIENT SAMPLE FOR ABO FORWARD AND REVERSE TYPING USING AN ALTERNATIVE COMMERCIALLY AVAILABLE METHOD (DIAMED CARD) AND THAT THEY HAD OBTAINED A NEGATIVE REACTION WITH THE ANTI-B REAGENT. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397501 ↗