North American Diagnostics recalls unapproved SARS CoV-2 rapid antigen test kits sold in the US. These kits lack FDA clearance and pose regulatory risks.
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
North American Diagnostics is recalling SARS CoV-2 rapid antigen test kits sold under brands like Oral Rapid Test and SML. These kits were distributed without FDA approval, which means they may not meet safety standards.
These test kits were sold without FDA approval, meaning they haven't been tested for safety and effectiveness. However, they do not pose an immediate physical hazard like fire or injury.
Anyone who purchased these test kits in the US. The risk is low because the kits were unapproved but not inherently dangerous in normal use.
Check for brands like Oral Rapid Test, Oral Rapid Antigen Test, or SML LDT Kits. Look for lot numbers FLUSA 1020-1 or batches 8, 10, and 12.
Identify the brand and lot number to confirm if your kit is affected.
The recall states these kits were sold without FDA approval, but they do not pose an immediate physical hazard. Safety is not explicitly stated.
The recall does not specify a remedy, so you can check if your kit matches the described brands and lot numbers.
Look for brands like Oral Rapid Test, Oral Rapid Antigen Test, or SML LDT Kits, and check for lot numbers FLUSA 1020-1 or batches 8, 10, and 12.
We’ve drafted a message you can send North American Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1401-2022 — North American Diagnostics North American Diagnostics Hello, I own a North American Diagnostics that is covered by recall Z-1401-2022 from North American Diagnostics. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
