Z-0093-2025Class III

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro...

Name: Z-0093-2025 Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro...
Creator: Beckman Coulter, Inc.
Published: 2024-07-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-16 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device on 2024-07-16. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0093-2025
Classification: Class III
Status: Open, Classified
Initiated: 2024-07-16
Posted: 2024-10-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: 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: 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 in commerce: 5589 units
Distribution: worldwide
Product codes and lots: UDI/DI 10837461002611, Lot Numbers: 432-24 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0093-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2025	Class III	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-16

Product code JJW

K072640Class IIrispec,ca/cb/ccIris Diagnostics / cleared 2007-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)