Beckman Coulter recalls Access Thyroglobulin calibrators from April 2023 that may decrease patient results by 11% due to calibration issues. Affected units have specific serial numbers.
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Beckman Coulter is recalling Access Thyroglobulin calibrators distributed in April 2023 because they may cause patient results to be 11% lower than they should be. This could lead to inaccurate test results if the calibrators are used without correction.
The calibrators distributed in April 2023 may cause patient test results to decrease by about 11% compared to expected values. This could lead to misdiagnosis if the decrease is not corrected.
Healthcare professionals using these calibrators for thyroid tests may be affected. Patients receiving tests with the recalled calibrators could experience inaccurate results.
Check for serial numbers: 233806, 234171, 234355, 234443, 234444, 234617, or 337940. These calibrators were distributed in April 2023.
Look for serial numbers 233806, 234171, 234355, 234443, 234444, 234617, or 337940 on the calibrators.
The calibrators distributed in April 2023 may cause patient test results to decrease by about 11% compared to expected values.
Check the serial numbers listed to see if your calibrators are affected. If they are, contact Beckman Coulter for further instructions.
Affected calibrators have serial numbers: 233806, 234171, 234355, 234443, 234444, 234617, or 337940.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0100-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0100-2024 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.
