Beckman Coulter recalls Access SARS CoV-2 lgG II Reagent (REF: C69057) due to potential false high results from specific 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 Reagent (REF: C69057) because certain software versions can multiply test results by 1000, causing falsely high readings. This could lead to incorrect health assessments if used without updating the software.
The reagent may produce results that are 1000 times higher than actual values when used with certain software versions (APF and AAF). This can cause incorrect health assessments if the false high results are interpreted as real positive tests.
Users of the Access SARS CoV-2 lgG II Reagent (REF: C69057) with specific software versions may get false high results. Laboratory staff and healthcare providers using this reagent are most at risk.
Check for the reagent product name 'Access SARS CoV-2 lgG II Reagent' with reference number REF: C69057. All lots are affected by this recall.
Ensure your system uses the latest software versions to prevent false results.
The reagent is safe to use if software versions are updated to prevent false high results.
Check for the reagent product name 'Access SARS CoV-2 lgG II Reagent' with reference number REF: C69057. All lots are affected.
Update your software versions to prevent false high results. No immediate action is needed beyond this update.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1905-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1905-2021 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.
