Recall Z-0118-2025— Beckman Coulter Inc.

Name: FDA recall Z-0118-2025
Creator: U.S. Food and Drug Administration
Published: 2024-07-31

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2024-07-31. It names one FDA 510(k) clearance: K963868. Product: IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.. Reason: Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU.

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-31
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)Beckman Instruments, Inc.·cleared 1997-02-10

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

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

Reason for recall

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

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