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

FDA device recall Z-0093-2025 · posted 2024-10-16 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJW

Quantity affected

5589 units

Distribution

worldwide

Date initiated

2024-07-16

Date posted

2024-10-16

Location

Miami, FL

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