Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Strips Due to Defect
Beckman Coulter is recalling a subset of iChem VELOCITY Urine Chemistry Strips because an incorrect pad may cause false negative results for leukocytes.
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 potential false negative diagnostic results, which is a significant quality issue but does not involve direct physical injury or high-risk pathogens, fitting the Moderate criteria for labeling/quality errors.
Plain-English summary
Beckman Coulter Inc. is recalling a subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry Strips, REF 800-7212. The recall involves 14,340 units that were distributed worldwide and nationwide in the United States.
The recall was initiated because a subset of the affected lot contains an incorrect pad placed in the location of the leukocytes pad. This defect results in control CB failure for leukocytes and may generate false negative erroneous results for leukocytes.
The iChem VELOCITY system is an in vitro diagnostic device used in clinical laboratories to automate urine chemistry analysis. It is not intended for point-of-care use or visual reading. Users should contact Beckman Coulter for further instructions on how to handle the affected strips.
The recalled product
- Product
- iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 14,340
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)
- Lot #7212154 A
Distribution
Distributed nationwide across the United States.
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