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U.S. Department of Health and Human Services

Class 1 Device Recall COVID19 Rapid Antigen Tests

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  Class 1 Device Recall COVID19 Rapid Antigen Tests see related information
Date Initiated by Firm November 28, 2022
Date Posted January 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-0929-2023
Recall Event ID 91321
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Products are labeled as:

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT


Green and white box under the brand DiagnosUS,

and,

White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Code Information Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q
Recalling Firm/
Manufacturer		 Universal Meditech Inc.
1320 E Fortune Avenue, Suite 102
Fresno CA 93725
For Additional Information Contact Michael M. Lin
702-871-9888
Manufacturer Reason
for Recall		 Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
FDA Determined
Cause 2		 No Marketing Application
Action On 12/29/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them Universal Meditech Inc. is recalling SARS-CoV-2 Antigen Rapid Test Kits due to test kits being distributed with any FDA pre-market approvals, clearances and/or authorizations. Test kits are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, or labelled and packaged in Green and white box under the brand name DiagnosUS, or packaged in White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING. Customer are instructed to: -Immediately stop distributing or using any of the abovementioned device in their remaining stock. -If they have already distributed the device to anyone else, please inform them of the product recall by forwarding this letter to them. -Acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending back to Universal Meditech, so that arrangements can be made to refund or an order replacement using FDA authorized devices. Note- this recall is for ALL devices under this trade name, regardless of their lot number and date of manufacture. For questions or assistance with this recall, contact Michael M. Lin, Legal Attorney Email: m@linlawgroup.com or Tel: +1(702)871-9888 (9AM to 5PM, PST, MON to FRI)
Quantity in Commerce 56,300 kits
Distribution U.S. Nationwide distribution in the states of CA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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