Beckman Coulter Recalls UIBC Reagent Lot 2690 Due to Erroneous Results
Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.
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. The hazard involves erroneous test results (false highs) rather than direct physical injury or contamination, fitting the criteria for moderate severity involving potential diagnostic error without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling 219 units of Unsaturated Iron Binding Capacity (UIBC) reagent, catalog number OSR61205, lot 2690. The product is an in vitro diagnostic (IVD) reagent used for the quantitative determination of UIBC in human serum and plasma on Beckman Coulter AU analyzers.
The manufacturer identified that the use of this specific lot will produce erroneously high patient results at the low end of the linear range. The affected units have an expiration date of 10/01/2021.
The recall involves worldwide distribution, including US nationwide distribution in California, Florida, and New Jersey, as well as distribution in Algeria, Egypt, the Philippines, and Taiwan. Healthcare facilities and laboratories should stop using the affected lot and contact Beckman Coulter for further instructions.
The recalled product
- Product
- UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 219
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 (2)
- LOT 2690
- Expiration date 10/01/2021
Distribution
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