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Safety Report: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results, USA

1 year ago •source fda.gov

Recall notice

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits - recalled due to inappropriate premarket or inaccurate test results photo #1

United States

Universal Meditech Inc. initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. Recalled products were manufactured from October 2021 to December 2021 and distributed in January 2022 to distributors in California and Texas. To date, there has not been any reported injury.

A recall of the same device has been previously conducted by SML Distribution LLC. Consumers who have Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits should stop using the device immediately and contact the distributor for product return.

- The following styles/models/UDI have been recalled:
Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
UDI: None
Model: Cassette
Quantity: 56,300

Products were distributed with “Skippack Medical Lab” branded Instructions for Use leaflet in three different packaging boxes identified below:
- Purple and white box under “Skippack Medical Lab” brand: (see image attached)
- Green and white box under “DiagnosUS” brand: (see image attached)
- White box without brand name: (see image attached)

Universal Meditech Inc. voluntarily recalled the product after becoming aware of the violative distribution notified by the FDA.

Company name: Universal Meditech Inc.
Brand name: Skippack Medical Lab, DiagnosUs
Product recalled: SARS-CoV-2 Antigen Rapid Test Kits
Reason of the recall: Products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.
FDA Recall date: February 10, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/universal-meditech-inc-issues-nationwide-recall-skippack-medical-lab-sars-cov-2-antigen-rapid-test

#medicaldevices #us

321

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