Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems and Strips
Beckman Coulter is recalling iChem VELOCITY urine chemistry systems and strips because loose or missing analyte pads may go undetected by the system.
What this means for you
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, and the hazard involves potential diagnostic inaccuracy due to undetected loose or missing pads, which fits the criteria for moderate severity without reported injuries or hospitalizations.
Plain-English summary
Beckman Coulter Inc. is recalling iChem VELOCITY Automated Urine Chemistry systems and iChem VELOCITY Urine Chemistry Strips. The recall involves 2,661 units total, with 1,424 units distributed in the United States. The affected products were distributed globally, including in the United States and Puerto Rico.
The recall was initiated because loose or missing analyte pads were found in several locations, including the strip vial, strip provider module, strip conveyor system, or waste container. These loose or missing pads are undetectable by the iChem VELOCITY System, which may affect the accuracy of urine chemistry results.
Healthcare facilities and users of the affected equipment should contact Beckman Coulter Inc. for instructions on how to address the issue. The recall covers all serial numbers of the listed catalog numbers.
The recalled product
- Product
- iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
- Manufacturer
- Beckman Coulter Inc.
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)
- all serial numbers
Distribution
Distributed in 1 state:
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