BIOCLONE 711220Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10758750003020), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.