Beckman Coulter Cholesterol Reagent Recalled for False Low Results
Beckman Coulter is recalling Cholesterol OSR6x16 reagent because Dipyrone may cause erroneous, false low results in cholesterol assays.
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 classified as FDA Class II, but the hazard is a diagnostic error (false low results) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling Cholesterol, Catalog No. OSR6x16, a system reagent intended for the quantitative determination of cholesterol concentrations in human serum on Beckman Coulter AU analyzers. The recall affects 43,877 units total, including 10,496 units in the US, distributed worldwide.
The recall was initiated because Beckman Coulter identified that Dipyrone (Metamizole) may cause erroneous, false low results in the Cholesterol OSR6X16 assay. This issue is part of a broader identification affecting several other assays, including Triglyceride, Uric Acid, Lactate, and Lipase.
Healthcare facilities and laboratories using this reagent should stop using the affected product and contact Beckman Coulter for instructions on how to proceed. The recall covers all lots of the product.
The recalled product
- Product
- Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum 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 lots
Distribution
Part of a larger recall action
This product is one of 5 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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