Beckman Coulter recalls Access SARS-CoV-2 Antigen Calibrators (REF: C68669) due to potential false positive results in SARS-CoV-2 tests. Affected units may lead to incorrect diagnoses.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators (REF: C68669) because they may cause false positive results in SARS-CoV-2 tests, leading to incorrect diagnoses. This affects lab users who rely on these calibrators for accurate testing.
The calibrators may produce false positive results when used in SARS-CoV-2 antigen tests. This could lead to incorrect diagnoses of COVID-19, potentially causing unnecessary isolation or treatment decisions.
Lab users who perform SARS-CoV-2 antigen tests with the recalled calibrators are most at risk. The recall applies to all units sold with the reference number C68669.
Check for the reference number C68669 on the calibrator packaging. All lots of this product are affected, as indicated by the recall notice.
Verify the reference number C68669 on the calibrator packaging to confirm if it is affected.
The recall is due to the potential for false positive results in SARS-CoV-2 antigen tests, which could lead to incorrect diagnoses.
Check for the reference number C68669 on the calibrator packaging. All lots of this product are affected.
The recall does not specify a remedy, so you should check the product details to confirm if it is affected and contact the manufacturer for further guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2256-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2256-2021 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.
