FDA Medical devices recall ·
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls recall
- Recall number
- Z-0093-2025
- Date
- (initiated July 16, 2024)
- Company / brand
- Beckman Coulter, Inc.
11800 Sw 147th Ave, Miami, FL, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 5589 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Why was it recalled?
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Distribution
worldwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-0093-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.