PlainRecalls
FDA Devices Critical Class I Ongoing

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Reported: July 13, 2022 Initiated: May 2, 2022 #Z-1277-2022

Product Description

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

Reason for Recall

Affected products were assembled off-site by individuals who may not have been properly trained.

Details

Units Affected
274,400 kits total
Distribution
US distribution in the state of Minnesota.
Location
Kansas City, MO

Frequently Asked Questions

What product was recalled?
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A. Recalled by American Contract Systems, Inc.. Units affected: 274,400 kits total.
Why was this product recalled?
Affected products were assembled off-site by individuals who may not have been properly trained.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2022. Severity: Critical. Recall number: Z-1277-2022.