Sky Medical recalls IgG/IgM diagnostic test kits for SARS-CoV- 2 that were distributed without emergency use authorization. This recall addresses potential risks from unapproved testing devices.
Distributed COVID test kits without emergency use authorization.
Sky Medical is recalling SARS-CoV-2 rapid test kits that were distributed without emergency use authorization. This means the tests may not be safe or reliable, and users should not rely on them for accurate results.
These tests were distributed without emergency use authorization, meaning they were not approved for safety or accuracy by health authorities. Using unapproved tests could lead to incorrect results, which might affect health decisions.
Anyone who purchased or used these SARS-CoV-2 rapid test kits from Sky Medical. People most at risk are those who used the tests for medical diagnosis without proper authorization.
The product is labeled as 'AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma'. It was sold by Sky Medical Supplies and Equipments LLC starting from the date indicated in the recall.
Look for the product name and manufacturer details on the test kit to confirm if it matches the recalled items.
The tests were distributed without emergency use authorization from health authorities, which means they may not be safe or accurate.
No, these tests were not approved for emergency use, so they may not provide reliable results.
The recall does not specify a remedy, so you should check with Sky Medical directly for guidance.
We’ve drafted a message you can send Sky Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1127-2021 — Sky Medical Sky Medical Hello, I own a Sky Medical that is covered by recall Z-1127-2021 from Sky Medical. 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.
