Beckman Coulter recalls Access SARS-CoV-2 lgG II Calibrator (REF C69058) due to potential false high results from incorrect software versions. All lots affected.
SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
Beckman Coulter is recalling its Access SARS-CoV-2 lgG II Calibrator (REF C69058) because certain software versions can cause test results to be 1000 times higher than they should be. This could lead to incorrect health assessments if used for COVID-19 testing.
The calibrator may produce numerical results that are 1000 times higher than actual values when using certain software versions. This happens because the device multiplies results incorrectly when running with specific assay protocol files and access assay files.
Users of the Access SARS-CoV-2 lgG II Calibrator for COVID-19 testing are affected. Laboratories using the device with specific software versions are most at risk.
Check if you have the Access SARS-CoV-2 lgG II Calibrator with reference number REF C69058. All lots of this product are affected by the recall.
Verify if your device is using the affected software versions that cause false high results.
The recall applies to laboratories using the device, not home users.
Check if your device has reference number REF C69058 and is using specific software versions that cause false high results.
No, but you should check software versions to ensure correct results.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1906-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1906-2021 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.
