Device recall
Z-0940-2021: Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel…
FDA device recall · Class III · Biomeme, Inc.
Key facts
| Recall number (Z-number) | Z-0940-2021 |
|---|---|
| Recall event | 87153 |
| Product | Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the… |
| Product code | QJR |
| Recalling firm | Biomeme, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 11, 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