Recall Z-1277-2022
American Contract Systems, Inc. · initiated May 2, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Codes / lots: UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Reason for recall
Affected products were assembled off-site by individuals who may not have been properly trained.
FDA-determined cause: Process control
Action taken
On May 2, 2022, the customer was notified by email. The customer was instructed to destroy or discard affected kits.
Details
- Recall number
- Z-1277-2022
- Initiated
- May 2, 2022
- Posted by FDA
- July 1, 2022
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Quantity
- 274,400 kits total
- Distribution
- US distribution in the state of Minnesota.
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1276-2022 Class I | Clean Catch Urine Kit NS 178489, AHMU58AAffected products were assembled off-site by individuals who may not have been properly trained. | 05/02/2022Open, Classified |