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Honored Contributor
Mindy D
Posts: 13,510
Registered: ‎05-23-2010

Recall of unapproved rapid tests from Universal Meditech Inc.

[ Edited ]

‎02-11-2023 08:44 AM - edited ‎02-11-2023 08:47 AM

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-na...

Recall page includes package photos. 

Below is quoted from the FDA page for this recall.

"Company Announcement Date:February 09, 2023FDA Publish Date:February 10, 2023Product Type:Medical DevicesReason for Announcement:

Products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.

Company Name:Universal Meditech Inc.Brand Name:

Skippack Medical Lab, DiagnosUs

Product Description:

SARS-CoV-2 Antigen Rapid Test Kits"

 

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