FDA Device recall Z-1401-2022
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand F…
- FDA Device
- Class I
- ongoing
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class I recall of SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand F… by North American Diagnostics, citing various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorizati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1401-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-06-15 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | North American Diagnostics |
| Distribution | US |
Product
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Reason
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Identifiers
| code_info | Lot: FLUSA 1020-1, Batches 8, 10, and 12 |
|---|
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-1401-2022%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.