Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors
Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient data/results) where specific physical injuries have not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Beckman Coulter Inc. is recalling 4,314 iChemVELOCITY Urine Chemistry Systems, including catalog numbers 700-7176-001, 700-7177-001, and B75502. These devices are used to automate urine chemistry analysis profiles using iChemVELOCITY Urine Chemistry Strips. The recall covers devices distributed worldwide.
The recall was initiated after customers reported incidents where the system reported the same Specimen Identifier (Specimen ID) with different results, different Medical Record Numbers (MRN), and different patient demographics. This data inconsistency could lead to incorrect patient identification and result attribution.
Healthcare facilities and customers should contact Beckman Coulter Inc. for instructions on how to stop using the affected devices and arrange for a return or replacement. The FDA has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 4,314
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)
- UDI: 10837461009375
- 10837461001751
- All Part Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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