Beckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Strips because increased sensitivity causes falsely elevated urobilinogen results.
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 is a false positive result (diagnostic error) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity recall involving labeling or performance issues without reported physical harm.
Plain-English summary
Beckman Coulter Inc. is recalling iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The recall involves 956,798 vials. The product was distributed nationwide, including Puerto Rico, as well as to military/government entities and foreign locations including Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.
The recall is due to an increase in the sensitivity of the urobilinogen reaction, which results in falsely elevated (false positive) urobilinogen patient results. The affected lot numbers begin with 7212143, excluding lots 7212146, 7212148, 7212160, 7212162, 7212163, and 7212164.
Healthcare providers and consumers should stop using the affected test strips and contact Beckman Coulter for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
- 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 (5)
- Lot numbers beginning with lot 7212143 except for: 7212146
- 7212148
- 7212160
- 7212162
- 7212163 and 7212164.
Distribution
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