Official recall record
Apo B Reagent, REF: OSR6143
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-04-23
- Country of alert
- Ireland
- Alert level
- Class III
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590010409
- Brand on record
- Beckman Coulter Ireland, Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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