The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The American Contract Systems (ACS) COVID Test Kit Nonsterile (a nasopharyngeal sample collection tray for COVID-19 testing, labeled as “COVID TEST KIT NONSTERILE 184312, AHCV18A”) 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).  

American Contract Systems 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. 

On May 1, 2022, American Contract Systems sent an Urgent Medical Device Recall letter to customers requesting that they take the following actions:

Customers were also asked to verify receipt and understanding of the recall letter by completing the attached Field Action Response Form and emailing it to angela.bunn@owens-minor.com. This action is requested even if the customer has no affected products. 

Customers with questions about this recall should contact Angela Bunn, director of Global Regulatory Affairs, at angela.bunn@owens-minor.com. 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.