Beckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure
Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of diagnostic reagents that do not meet their specified sensitivity performance. While no illnesses or injuries have been reported, inadequate test sensitivity could result in false-negative results, potentially delaying diagnosis of infections or other medical conditions.
Plain-English summary
Beckman Coulter Inc. is recalling two lots of IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent due to failure to meet sensitivity specifications. The affected lots are M307362 and M309410, catalog number 447610, with a total of 12,102 reagent units distributed.
The IGM reagent is used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1 to measure immunoglobulin M levels in human serum using rate nephelometry. The firm identified that the recalled lots are not meeting the sensitivity statement in the product's Instructions for Use, which could result in inaccurate test results.
The affected reagent has been distributed throughout the United States, including in Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, Missouri, North Dakota, New York, Ohio, Pennsylvania, and Texas. International distribution includes Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, and Turkey.
The recalled product
- 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.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- sensitivity-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
Distribution
Distributed in 15 states:
- AZ
- CA
- CO
- FL
- GA
- HI
- IL
- MA
- MI
- MO
- ND
- NY
- OH
- PA
- TX
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