Device recall
Z-2665-2023: therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the…
FDA device recall · Class II · Qiagen GmbH
Key facts
| Recall number (Z-number) | Z-2665-2023 |
|---|---|
| Recall event | 92991 |
| Product | therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD) |
| Product code | OWD |
| Recalling firm | Qiagen GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P110027, P110027S012 |
| FEI number | 3004013603 |
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