Universal Meditech Inc. recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits sold without FDA approval. Products labeled as green and white boxes with model numbers 550-10. Consumers should check labels for lot numbers.
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Universal Meditech Inc. is recalling Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits that were distributed without FDA approval. These kits may not be safe for use as they lack required regulatory clearance.
These test kits were distributed without FDA market approval, clearance, or Emergency Use Authorization. Using unapproved tests could lead to incorrect results, which might affect health decisions.
Anyone who purchased the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits with model numbers 550-10. People using these kits for testing without FDA approval are at risk of inaccurate results.
Look for products labeled as 'Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green' with model number 550-10. Check for lot numbers: UL-AG-2111-01-Q through UL-AG-2112-02-Q.
Look for the model number 550-10 and lot numbers listed in the description.
These kits were distributed without FDA market approval, clearance, or Emergency Use Authorization.
Model number 550-10 with lot numbers UL-AG-2111-01-Q through UL-AG-2112-02-Q.
The recall does not specify a stop-use instruction, but the kits lack FDA approval, so they may not be safe.
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-0929-2023 — Skippack Medical Lab Skippack Medical Lab Hello, I own a Skippack Medical Lab that is covered by recall Z-0929-2023 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.
