Device recall
Z-0929-2023: Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit…
FDA device recall · Class I · Universal Meditech Inc.
Key facts
| Recall number (Z-number) | Z-0929-2023 |
|---|---|
| Recall event | 91321 |
| Product | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING |
| Product code | QKP |
| Recalling firm | Universal Meditech Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3011908678 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database