Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results
Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to potential false abnormal results, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling 925 units of IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Product Number 447070. The recall affects Lot numbers M012376 and M101865. These products were distributed nationwide in the United States and in Canada.
The recall was initiated after Beckman Coulter confirmed customer reports of quality control shifts, lot-to-lot variation, and an increase in the percentage of patient samples recovering greater than 20 IU/mL. The company determined that the identified lots might produce false abnormal results when used in conjunction with the Beckman Cal 5 Plus system for quantitative determination of human rheumatoid factor concentrations.
Healthcare facilities and laboratories that possess these specific lots should stop using the reagent and contact Beckman Coulter for instructions on return or replacement. The source text does not specify a deadline or additional consumer actions beyond the recall notification.
The recalled product
- Product
- IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations i
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 925
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)
- Lot# M012376 and M101865
Distribution
Distributed nationwide across the United States.
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