Device recall
Z-0513-2021: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic…
FDA device recall · Class II · Biomeme, Inc.
Key facts
| Recall number (Z-number) | Z-0513-2021 |
|---|---|
| Recall event | 86757 |
| Product | The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative… |
| Product code | QJR |
| Recalling firm | Biomeme, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2021 |
| FEI number | 3014117298 |
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