Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips
Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is intermittent false positive results in a diagnostic control, which affects laboratory test accuracy rather than causing direct patient harm.
Plain-English summary
Beckman Coulter is recalling the IRISpec CA/CB/CC glucose control because it produces intermittent false positive results when used with iChemVelocity Urine Chemistry Strips. The company discovered an increase in customer complaints about this issue.
Approximately 3657 units were distributed to the United States, Canada, Brazil, Korea, Mexico, Puerto Rico, and Taiwan. The product is a diagnostic control material used in clinical laboratory testing.
No illnesses or injuries have been reported. Customers with this product should contact Beckman Coulter for instructions.
The recalled product
- Product
- BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- Affected units
- 3,657
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)
- UDI/DI 10837461002611
- Lot 565-21: 11-30-2022
Distribution
Distributed in 1 state:
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