FDA Medical Device Recalls (openFDA)
Universal Meditech Inc.: 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
- Recall number
- Z-0929-2023
- Recalling firm
- Universal Meditech Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2022-11-28
- Posted
- 2023-01-27
- Terminated
- not on file
- Reason
- Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
- Root cause
- 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
- 56,300 kits
- Distribution
- U.S. Nationwide distribution in the states of CA, and TX.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3011908678
- Firm city
- Fresno
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28