FDA Recall
Open, Classified
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Recall: Z-1277-2022
·
Initiated May 2, 2022
Recall
- Recall Number
- Z-1277-2022
- Event Number
- 90324
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3003419114
- Product Code
- JSM
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 2, 2022
- Posted
- July 1, 2022
- Address
- 2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648
Description
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Reason
Affected products were assembled off-site by individuals who may not have been properly trained.
Action
On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
Distribution
US distribution in the state of Minnesota.
Quantity
274,400 kits total