Nasopharyngeal sample collection tray for COVID-19 testing — Class I medical device recall Z-1277-2022
Ongoing recall by American Contract Systems, Inc., reported 2022-07-13, distributed in MN. Affected products were assembled off-site by individuals who may not have been properly trained.
| Recall number | Z-1277-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Inc., Kansas City, MO, United States |
| Recall initiated | 2022-05-02 |
| Classified | 2022-07-01 |
| Reported by FDA | 2022-07-13 |
| Distributed | MN |
| Quantity | 274,400 kits |
| UPC / GTIN / UDI-DI | 00191072121233 |
| Lot numbers | 657211, 672211, 721211, 974221, 980221, 994221 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1277-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.