American Contract Systems, Inc. Recall 90324
Description: Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
American Contract Systems, Inc. Recall 90324 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1277-2022 |
| Event ID | 90324 |
| Event Description | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A |
| Product Type | Devices |
| Distribution | US distribution in the state of Minnesota. |
| Quantity | 274,400 kits total |
| Recall Reason | Affected products were assembled off-site by individuals who may not have been properly trained. |
| Device Classification | 20220713 |
| Device Code Info | UDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221 |
| Center Classification Date | 20220701 |
| Recall Initiation Date | 20220502 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | Letter |
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