Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0093-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: July 16, 2024

Date Posted: October 23, 2024

Recall Number: Z-0093-2025

Event ID: 95159

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.

Status: Ongoing

Product Quantity: 5589 units

Code Information:

UDI/DI 10837461002611, Lot Numbers: 432-24 and higher

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated