FDA Device recall Z-0944-2022
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
- FDA Device
- Class I
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class I recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) by Sml Distribution, citing the product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0944-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-03-04 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sml Distribution |
| Distribution | US |
Product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Reason
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Identifiers
| code_info | All lots: 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0944-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.