—#209632

Product

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

FDA product code: JJW — Urinalysis Controls (Assayed And Unassayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K072640
Affected lot / code info: UDI/DI 10837461002611, Lot Numbers: 432-24 and higher

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2024-07-16
Posted by FDA: 2024-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.