Beckman Coulter Recalls Creatinine Reagents for Calibration Instructions
Beckman Coulter is recalling Creatinine reagents to provide updated instructions for calibration stability and quality control frequency.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a voluntary precautionary measure to update instructions for calibration and quality control, which aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Beckman Coulter Inc. is recalling Creatinine reagents, Part Numbers OSR6178 and OSR6678. These products are system reagents used for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
The recall is being conducted to include additional information and instructions in the Instructions for Use (IFU) and Setting Sheet. These updates relate to calibration stability and quality control frequency to assure product performance.
The recall affects 57,962 units, with 50,452 units distributed in the US. Distribution was worldwide, including the US, Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, and Costa Rica. Users should refer to the updated IFU and Setting Sheet for the new calibration and quality control instructions.
The recalled product
- Product
- Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- All
Distribution
Distributed nationwide across the United States.
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