FDA MedWatch - COVID Test Kits Nonsterile and Clean Catch Urine Kits by American Contract Systems
U.S. Food and Drug Administration sent this bulletin at 07/19/2022 06:05 PM EDT
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: COVID Test Kits Nonsterile and Clean Catch Urine Kits by American Contract Systems: Class I Recall - Due to Risk of False Results
AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory
ISSUE: American Contract Systems (ACS) is recalling the COVID Test Kit Nonsterile and Clean Catch Urine Kit products because they were assembled in an uncontrolled facility by people without proper training. As a result, the company is unable to verify that the kits will perform as expected. These kits have the potential to give false negative or false positive results or lead to misinterpretation of test results.
Use of these affected products could cause serious adverse health consequences and death.
The company has not received any complaints or reports of injuries or deaths associated with the use of these kits.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND:
The ACS COVID Test Kit Nonsterile includes a nasopharyngeal swab and Universal Transport Media and is intended to collect samples that are used to detect infection with SARS-CoV-2, the virus that causes COVID-19.
The ACS Clean Catch Urine Kit is used to collect urine for further testing, including to test for potential urinary tract infection (UTI).
RECOMMENDATIONS: On May 1, 2022, ACS sent an Urgent Medical Device Recall letter to customers requesting that they take the following actions:
Review inventory and segregate affected product.
Destroy affected kits and provide evidence to ACS.
Report adverse events associated with this product to the company.
Customers should verify receipt and understanding of the recall letter by completing the Field Action Response Form and emailing it to the company. This action is requested even if the customer has no affected products.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
