Device recall
Z-0937-2021: therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in…
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-0937-2021 |
|---|---|
| Recall event | 87047 |
| Product | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121 |
| Product code | OWD |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2022 |
| PMA numbers | P190001, P190004 |
| FEI number | 3003572099 |
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