BIOCLONERecalls & reported problems across all models
Ortho-Clinical Diagnostics, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BIOCLONE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of BIOCLONE by Ortho-Clinical Diagnostics, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2023 and Jan 8, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
BIOCLONE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1836-2025 · Root cause: Storage · Recall details · FDA record ↗
Most reported BIOCLONE problems
Device problems
- False Positive Result6
- False Negative Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
BIOCLONE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall0 reports
- 7 reports
- 1 report
Recent BIOCLONE adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025False Negative Result; False Negative Result
(B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR ONE DONOR UNIT WHEN PERFORMING ABO UNIT CONFIRMATION TYPING UTILIZING ORTHO ANTI-A BIOCLONE LOT BAA632A, EXPIRY 21JUN2025, IN MANUAL TUBE METHOD. COMPLAINANT: (B)(6); SENIOR TECHNICIAN (B)(6); (B)(6) MEDICAL CENTER (B)(6) DATE OF EVENT: 05DEC2024 (REPORTED (B)(6)2024) REAGENT: ORTHO ANTI-A BIOCLONE LOT BAA632A, EXPIRY 21JUN2025, MANUFACTURE 21JUN2023. DONOR INFORMATION: ONE DONOR UNIT LABELED A POSITIVE. UNIT ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY PERFORMED REPEAT ABO FORWARD TESTING ON ONE DONOR UNIT IN MANUAL TUBE METHOD FOLLOWING DISCREPANT RESULTS IN MTS GEL METHOD AND THEY OBTAINED AN ABO FORWARD TYPE OF O POSITIVE WHEN A POSITIVE WAS EXPECTED. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER STATED THEY RETURNED THE UNIT TO THEIR BLOOD SUPPLIER, (B)(4), AND THAT (B)(4) REPORTED THAT THE UNIT RETYPED AS SEROLOGICAL O POSITIVE AND CONCLUDED THE ABORH OF THE UNIT AS AN A SUBGROUP RH POSITIVE. (B)(4) ALSO INDICATED THAT THE UNIT WOULD BE SENT TO THE BLOOD CENTER, CREATIVE TESTING SOLUTIONS (CTS), FO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21101093 ↗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 ↗
Other Ortho-Clinical Diagnostics, Inc. products
All Ortho-Clinical Diagnostics, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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