First SIGN SARS-CoV-2 Antigen Tests sold without FDA approval in California. These tests lack Emergency Use Authorization and are not cleared for U.S. commercial distribution.
Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S.
First SIGN SARS-CoV-2 Antigen Tests sold in California without FDA approval are being recalled. Using these tests could lead to inaccurate results since they haven't been cleared for U.S. use.
These tests were sold without FDA Emergency Use Authorization or approval for U.S. distribution. Using them could result in inaccurate results, which might lead to incorrect health decisions.
People who purchased these tests from a California pharmacy. Those using unapproved tests may get unreliable results.
Check for model number FSSA-CK20 on the test kit. The lot numbers include F0301214078, F1227210039, and others listed in the recall notice.
Look for model number FSSA-CK20 on the test kit.
The recall states these tests were sold without FDA approval, so they may not be safe or accurate for U.S. use.
Check for model number FSSA-CK20 and lot numbers like F0301214078 or F1227210039.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send First SIGN to request your refund or repair — edit it as you like.
Subject: Recall Z-0892-2022 — First SIGN First SIGN Hello, I own a First SIGN that is covered by recall Z-0892-2022 from First SIGN. 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.
