Beckman Coulter recalls IRISpec CA/CB/CC control (REF 900-7211) due to false positive glucose results when used with iChemVelocity urine strips. Affected units sold from November 2022.
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Beckman Coulter is recalling its IRISpec CA/CB/CC control devices because they can give false high glucose readings when used with specific urine test strips. This could lead to incorrect health decisions if someone relies on these results.
The IRISpec control device can produce false positive glucose results when used with iChemVelocity urine strips. This means urine tests might show higher glucose levels than actually present, potentially causing unnecessary health concerns or incorrect treatment decisions.
Users of the IRISpec CA/CB/CC control devices with iChemVelocity urine strips (PN 800-7212) who test for glucose in urine. People with diabetes or other conditions requiring regular urine glucose checks are most at risk.
Check for the model number 900-7211 on the device. Units were sold from November 2022 with lot number 565-21.
Look for the model number 900-7211 on the IRISpec control device.
Beckman Coulter has received customer complaints about false positive glucose results when the IRISpec control device is used with iChemVelocity urine strips.
The recall record does not specify a remedy or action for affected units.
The recall indicates a potential for false positive results, which could lead to incorrect health decisions, but the record does not mention serious injury risks.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0777-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0777-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
