Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls… recallZ-0093-2025 · Beckman Coulter, Inc. · initiated Jul 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees beginning on 07/15/2024 by letter delivered by either USPS first class mail or email. The notice explained the issue, potential impact, and provided updated QC ranges for Glucose in the Analyzer. The information is to be shared with all affected parties. For questions: please contact Customer Support Center or your local representative; From our website: http://www.beckmancoulter.com By phone: Call 800-526-7694 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.
Recall details
- Recall number
- Z-0093-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 16, 2024
- Posted by the FDA
- Oct 16, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 5589 units
- Product code
- JJW
- FDA submissions
- K072640
- Distribution
- worldwide
Product description
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Code information (models, lots, serial numbers)
UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IRISpec CA/CB/CC URINE CHEMSITRY CONTROLSBeckman Coulter Ireland Inc. · Urinalysis Controls (Assayed And Unassayed)3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page