Skippack Medical Lab recalls unapproved SARS-CoV-2 antigen rapid test kits sold in the US. These tests lack FDA authorization and may not be safe or effective.
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Skippack Medical Lab is recalling all versions of their SARS-CoV-2 antigen rapid test kits sold in the US because they were distributed without FDA approval. This means the tests may not work correctly or could be unsafe for use.
The tests were distributed without FDA authorization, meaning they haven't been proven safe or effective for use in the US. This could lead to inaccurate results, which might cause false negatives or positives.
Anyone who purchased or used these unapproved test kits in the US is affected. People who rely on these tests for accurate COVID-19 detection are at risk of incorrect results.
Check for the model numbers UL-AG-2110-05-Q, UL-AG-2111-02-Q, UL-AG-2112-01-Q, UL-AG-2112-02-Q, or UL-AG-2201-03-Q on the test kit packaging. These kits were sold in the US without FDA approval.
Look for the model numbers listed on the test kit packaging to confirm if it's part of the recall.
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
The recall record states the tests were distributed without FDA approval, so they may not be safe or effective for use.
The recall record does not specify a remedy, so the official notice does not state what to do with the recalled items.
We’ve drafted a message you can send Skippack Medical Lab to request your refund or repair — edit it as you like.
Subject: Recall Z-0944-2022 — Skippack Medical Lab Skippack Medical Lab Hello, I own a Skippack Medical Lab that is covered by recall Z-0944-2022 from Skippack Medical Lab. 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.
