American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
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.
- Product Names: COVID Test Kit Nonsterile and Clean Catch Urine Kit
- Product Codes: JSM
- Lot Numbers: See recall database entry
- Distribution Dates: February 1, 2021, to March 31, 2022
- Devices Recalled in the U.S.: 166,400
- COVID Test Kit Nonsterile (a nasopharyngeal sample collection tray for COVID-19 testing, labeled as “COVID TEST KIT NONSTERILE 184312, AHCV18A”): 99,900 distributed and 5,000 undistributed
- Clean Catch Urine Kit: 61,500
- Date Initiated by Firm: May 1, 2022
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).
Reason for Recall
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.
Who May be Affected
- People who may have had a nasopharyngeal sample collected using the COVID Test Kit Nonsterile or a urine sample collected using the ACS Clean Catch Urine Kit.
- Health care providers and other organizations who collected nasopharyngeal samples using the COVID Test Kit Nonsterile to test for SARS-CoV-2 or who collected urine samples using the ACS Clean Catch Urine Kit.
What to Do
On May 1, 2022, American Contract Systems 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 ACSCH@amconsys.com.
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 email@example.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 firstname.lastname@example.org.
How do I report a problem?
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.