Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Analyzers
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may result in erroneous diagnostic results (Specific Gravity). Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling 4,314 units of the iChem VELOCITY Urine Chemistry Analyzer. The recall covers units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international locations.
The recall is due to an issue affecting the Specific Gravity chemistry settings. This defect prevents the trigger of a chemistry system flag (S3), which may result in erroneous Specific Gravity (SG) results. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and users should check their device serial numbers and software versions against the list provided in the official recall notice to determine if their units are affected. Users should contact Beckman Coulter for instructions on how to resolve the issue.
The recalled product
- Product
- iChem VELOCITY Urine Chemistry Analyzer
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 4,314
Distribution
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