Z-0929-2023Class I

Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1...

Name: Z-0929-2023 Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1...
Creator: Universal Meditech Inc.
Published: 2022-11-28
License: https://open.fda.gov/license/

Universal Meditech Inc. / initiated 2022-11-28 / Open, Classified

FDA source

Universal Meditech Inc. began a recall of 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... on 2022-11-28. FDA classified it as Class I and gives the reason as "Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0929-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-11-28
Posted: 2023-01-27
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
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
FDA 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: [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0929-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0929-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)