Reported Oct 23, 2024 · Ongoing
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog Number447610
- UDI-DI code15099590221195
- Lot NumbersM307362 M309410
- Amount recalled
- 12,102 reagents
Where it was sold
Why it was recalled
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
This product could cause temporary or reversible health problems — stop using it.
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