Beckman Coulter recalls Apo B Reagent REF OSR6143 due to potential incorrect patient results from calibration errors. The risk is considered negligible or limited by the manufacturer.
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.
Beckman Coulter is recalling Apo B Reagent REF OSR6143 because an error in the calibration sheet could cause inaccurate patient results. This issue is unlikely to cause serious health risks as the manufacturer states the risk is negligible.
The reagent's calibration sheet contains an incorrect value that can cause test results to be up to 42% higher than expected. This error could lead to inaccurate patient results, but the manufacturer says the health risk is negligible.
Patients using this reagent for APO B blood tests may be affected. Laboratory staff handling the reagent are most at risk due to potential calibration errors.
Check for the reagent label with REF OSR6143 and lot number 2631/UDI: 15099590010409. This product was sold by Beckman Coulter Ireland, Inc.
Look for the reagent label with REF OSR6143 and lot number 2631/UDI: 15099590010409.
The manufacturer states the risk to health is negligible or limited, so it is not considered dangerous.
The recall does not specify a remedy, so no action is required beyond checking the label.
The error can cause results to be up to 42% higher than expected, but the manufacturer says this risk is negligible.
We’ve drafted a message you can send Beckman Coul: Ireland to request your refund or repair — edit it as you like.
Subject: Recall Z-1815-2025 — Beckman Coul: Ireland Beckman Coul: Ireland Hello, I own a Beckman Coul: Ireland that is covered by recall Z-1815-2025 from Beckman Coul: Ireland. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
