Recall Z-1815-2025— Beckman Coulter Ireland, Inc.

Name: FDA recall Z-1815-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-23

Class III · Ongoing

Class III FDA medical device recall by Beckman Coulter Ireland, Inc., initiated 2025-04-23. It names one FDA 510(k) clearance: K952466. Product: Apo B Reagent, REF: OSR6143. Reason: 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..

Recalling firm: Beckman Coulter Ireland, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2025-04-23
Firm location: O'Callaghan'S Mills, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.·cleared 1995-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Apo B Reagent, REF: OSR6143

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.