Beckman Coulter Recalls iChemVELOCITY Strips Due to Pad Switching Error
Beckman Coulter is recalling iChemVELOCITY Strips because the Leukocyte and Compensation pads were switched on some vials of lot 7212269M.
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 source text describes a manufacturing defect (pad switching) but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter, Inc. is recalling iChemVELOCITY Strips, Catalog 800-7212, because the Leukocyte and Compensation pads were switched on some vials of lot number 7212269M. The recall involves 10,822 vials.
The affected product was distributed in the US, including Puerto Rico, Canada, and Taiwan. The specific UDI for the recalled items is 10837461002628.
Users should check their inventory for iChemVELOCITY Strips with lot number 7212269M and stop using them. They should contact Beckman Coulter, Inc. for further instructions on how to return or dispose of the affected product.
The recalled product
- Product
- iChemVELOCITY Strips, Catalog 800-7212
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- Affected units
- 10,822
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 (3)
- Catalog 800-7212
- UDI 10837461002628
- Lot 7212269M
Distribution
Distributed in 1 state:
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