Beckman Coulter recalls IRISpec CA/CB/CC control kits with potential glucose measurement failures. Affected units include specific catalog numbers and lots. Consumers should contact the manufacturer for details.
IRISpec CA failures for glucose.
Beckman Coulter is recalling IRISpec CA/CB/CC control kits that may fail to measure glucose correctly. This could lead to inaccurate test results if used in medical devices.
The IRISpec CA control kits may fail to measure glucose accurately, leading to incorrect test results. This could affect the reliability of medical testing if used in devices that require precise glucose measurements.
Users of Beckman Coulter IRISpec CA control kits with catalog number 800-7211 and lot numbers 583-21 or higher are affected. Patients using these kits for medical testing are most at risk.
Check for catalog number 800-7211 and lot numbers 583-21 or higher on the control kit packaging. The kit contains three 100 mL bottles of CA Control, CB Control, and CC Control.
Reach out to Beckman Coulter for specific instructions on how to handle the affected control kits.
The catalog number is 800-7211.
Lot numbers 583-21 and higher are affected.
Check the catalog number 800-7211 and lot numbers 583-21 or higher on the packaging.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0984-2022 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0984-2022 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.
