Universal Meditech Inc.: Medical Device Recall in 2023 - (Recall #: Z-0929-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: November 28, 2022

Date Posted: February 8, 2023

Recall Number: Z-0929-2023

Event ID: 91321

Reason for Recall:

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Status: Ongoing

Product Quantity: 56,300 kits

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

Distribution Pattern:

U.S. Nationwide distribution in the states of CA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated