Beckman Coulter iChemVELOCITY Urine Chemistry System Recall for Incorrect Settings
Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.
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 hazard involves potential for erroneous diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Beckman Coulter Inc. is recalling 2,225 units of the iChemVELOCITY Urine Chemistry System. The affected devices are in vitro diagnostic instruments used in clinical laboratories to automate urine chemistry analysis. The recall covers units with North American configuration settings that were distributed worldwide, including in the United States, Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, and Turkey.
The recall was initiated because there is a potential for incorrect settings to be installed on the analyzers. If International settings are installed on North American units, the device may generate erroneous, false low results for certain analytes at specific concentrations. Additionally, if output settings are configured with colors different from those specified in the Instructions for Use, the device will report incorrect colors for the urine sample.
Clinical laboratories and healthcare facilities should contact Beckman Coulter to verify the configuration of their iChemVELOCITY systems. Users should ensure that the devices are set to the correct North American configuration and that output color settings match the manufacturer's instructions to prevent inaccurate diagnostic results.
The recalled product
- Product
- BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,225
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 Fielded Serial Numbers with North American Configuration settings
Distribution
Distributed nationwide across the United States.
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