Beckman Coulter recalls ACCESS SARS-CoV-2 Antigen QC (REF: C68670) due to potential false positive results. This may lead to incorrect COVID-19 diagnoses. Affected units include all lots.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen QC test kits because they might give false positive results, which could lead to incorrect COVID-19 diagnoses. This recall affects all units sold and is important for accurate testing.
The test kits may produce false positive results, meaning they could indicate a COVID-19 infection when none exists. This risk leads to incorrect diagnoses and potential unnecessary isolation or treatment.
Healthcare professionals and labs using the ACCESS SARS-CoV-2 Antigen QC test kits are affected. Those who rely on these kits for COVID-19 testing may face incorrect results.
Check for the product name 'ACCESS SARS-CoV-2 ANTIGEN QC' with reference number C68670. All lots of this product are affected.
Identify the product name and reference number C68670 to confirm if your kit is affected.
The ACCESS SARS-CoV-2 Antigen QC test kits may generate false positive results, which could lead to incorrect COVID-19 diagnoses.
The recall does not specify a remedy, so check the product details to confirm if it's affected and contact Beckman Coulter for further guidance.
The recall describes a potential for false positive results, not physical injury. This is a low-risk issue related to test accuracy.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2257-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2257-2021 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.
