Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects
Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.
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, and the source text describes a manufacturing inspection failure without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling six iChem VELOCITY Automated Urine Chemistry Systems, including the Computerless model. The affected units are identified by Catalog #700-7176-001 (Serial numbers V04494 and CV04015) and Catalog #700-7177-001 (Serial numbers CV04012, CV04013, CV04014, and CV04017). These in-vitro diagnostic devices are used to automate urine chemistry analysis profiles.
The recall was initiated because the Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity. This lack of inspection represents a potential quality control failure in the manufacturing process.
The devices were distributed in the United States to the states of Alabama, Iowa, Georgia, and Florida. Users of these specific serial numbers should contact Beckman Coulter Inc. for further instructions on how to address the defect.
The recalled product
- Product
- iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 6
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)
- Catalog 700-7176-001 - Serial numbers V04494 and CV04015
- Catalog 700-7177-001 - Serial numbers CV04012
- CV04013
- CV04014
- and CV04017.
Distribution
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