FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
- Recall number
- Z-0093-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
- Status
- Open, Classified
- Initiated
- 2024-07-16
- Posted
- 2024-10-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 5589 units
- Distribution
- worldwide
- Lot, serial or model codes
- UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
- 510(k) numbers
- ["K072640"]
- PMA numbers
- not on file
- Product code
- JJW
- Firm FEI
- 3000203293
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28