Beckman Coulter recalls IGM Immunoglobulin M Reagent REF 447610 due to sensitivity problems in immunochemistry tests. Affected lots M307362 and M309410 may not meet required sensitivity levels.
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Beckman Coulter is recalling IGM Immunoglobulin M Reagent REF 447610 because some batches don't meet the sensitivity standards specified in the user manual. This could lead to inaccurate test results in immunochemistry systems.
The reagent may not meet the sensitivity requirements stated in the user manual. This could cause inaccurate test results when used with the IMMAGE Immunochemistry Systems and Calibrator 1.
Laboratory users who have the IGM reagent with lot numbers M307362 or M309410 are affected. Those performing immunoglobulin M tests using this reagent are most at risk.
Check the lot number on the reagent container. Affected lots are M307362 and M309410. The product is sold under catalog number 447610.
Look for lot numbers M307362 or M309410 on the reagent container.
Beckman Coulter's IGM Immunoglobulin M Reagent REF 447610.
Lot numbers M307362 and M309410.
The reagent does not meet the sensitivity requirements specified in the user manual.
The recall record does not specify a remedy for this product.
We’ve drafted a message you can send Beckman Coul: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0118-2025 — Beckman Coul: Inc. Beckman Coul: Inc. Hello, I own a Beckman Coul: Inc. that is covered by recall Z-0118-2025 from Beckman Coul: Inc.. 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.
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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.
