Beckman Coulter recalls IRISPEC CA/CB/CC Urine Chemistry Controls (REF 800-7211/7702) due to intermittent glucose control failures causing false positives with iChemVELOCITY strips. This may delay diagnosis of metabolic disorders and kidney issues.
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.
Beckman Coulter is recalling urine chemistry controls that sometimes give false positive glucose results when used with specific urine test strips. This could delay diagnosis of conditions like kidney problems or infections if not caught early.
The urine controls sometimes fail to detect glucose properly, causing false positive results when used with specific urine test strips. This could lead to delayed diagnosis of metabolic disorders, kidney function issues, or urinary tract infections if the false results aren't noticed.
Users of Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls (catalog numbers REF 800-7211 and 800-7702) with iChemVELOCITY analyzers. Laboratory staff and healthcare providers who run these tests are most at risk.
Check for catalog numbers REF 800-7211 or 800-7702 on the urine chemistry controls. The lot numbers start with 432-24. These products were sold with iChemVELOCITY analyzers.
Look for lot numbers starting with 432-24 on the urine chemistry controls.
Reach out to Beckman Coulter for guidance on whether your controls are affected.
The recall does not require immediate stop use; the issue is intermittent and not all units are affected.
False positive glucose results may delay diagnosis of metabolic disorders, kidney issues, or infections.
Check for catalog numbers REF 800-7211 or 800-7702 and lot numbers starting with 432-24.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0093-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0093-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
