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

FDA device recall Z-0929-2023 · posted 2023-01-27 · Open, Classified

Recall details

Recalling firm

Universal Meditech Inc.

Reason for recall

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

Action taken

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)

Root cause

No Marketing Application

Status

Open, Classified

Product code

QKP

Quantity affected

56,300 kits

Distribution

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

Date initiated

2022-11-28

Date posted

2023-01-27

Location

Fresno, CA