Device recall
Z-2978-2020: The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive…
FDA device recall · Class II · Life Technologies Corporation
Key facts
| Recall number (Z-number) | Z-2978-2020 |
|---|---|
| Recall event | 86204 |
| Product | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar… |
| Product code | QJR |
| Recalling firm | Life Technologies Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2022 |
| FEI number | 3009976420 |
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