Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit — Class I medical device recall Z-0944-2022
Ongoing recall by SML Distribution, LLC, reported 2022-05-11, distributed nationwide. The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
| Recall number | Z-0944-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SML Distribution, LLC, tyrone, PA, United States |
| Recall initiated | 2022-03-04 |
| Classified | 2022-05-03 |
| Reported by FDA | 2022-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 209,450 units |
| Lot numbers | UL-AG-2110-05-Q, UL-AG-2111-02-Q, UL-AG-2112-01-Q, UL-AG-2112-02-Q, UL-AG-2201-03-Q |
Product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Reason for recall
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
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-0944-2022. 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.