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

Recall date

July 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0093-2025

FDA classification

Class III

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

worldwide

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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