Reported Jun 4, 2025 · Ongoing
Apo B Reagent, REF: OSR6143
Beckman Coulter Ireland, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Ireland, Inc. · Lismeehan · O'Callaghan'S Mills, N/A · N/A
Is this the product you have?
- Apo B Reagent
- REFOSR6143
- Lot codes and dates
- Lot # 2631/UDI: 15099590010409
- Amount recalled
- 2747 units
Where it was sold
Why it was recalled
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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