Beckman Coulter recalls Access SARS-CoV-2 IgG (1st IS) Assay reagents due to insufficient evidence for Emergency Use Authorization. Affected units include specific lot numbers and UDI codes.
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Beckman Coulter is recalling Access SARS-CoV-2 IgG (1st IS) Assay reagents because the emergency use authorization process did not provide enough evidence to approve them for distribution. This recall affects specific lot numbers and UDI codes of the reagents.
The recall is based on the fact that the manufacturer's submission for Emergency Use Authorization (EUA) did not contain sufficient evidence to be granted EUA authorization. This means the reagents may not meet the required safety and efficacy standards for emergency use.
Users of the Access SARS-CoV-2 IgG (1st IS) Assay reagents with specific lot numbers and UDI codes are affected. Healthcare facilities or labs using these reagents are most at risk.
Check for the part numbers C74339, C74340, or C74341 and specific lot numbers (124466, 124467, 124468, 124758, 124708) on the reagent packaging. The UDI codes are also listed in the recall notice.
Identify the part numbers and lot numbers on the reagent packaging to confirm if it is affected.
Beckman Coulter is recalling these reagents because their submission for Emergency Use Authorization did not contain sufficient evidence to be granted EUA authorization.
The affected products include Access SARS-CoV-2 IgG (1st IS) Assay reagents with part numbers C74339, C74340, or C74341 and specific lot numbers (124466, 124467, 124468, 124758, 124708).
The recall does not specify a stop-use action; affected users should check their product details to confirm if they have the recalled items.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2508-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2508-2021 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.
