Device recall
Z-1300-2023: PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c)…
FDA device recall · Class II · Entopsis, Inc.
Key facts
| Recall number (Z-number) | Z-1300-2023 |
|---|---|
| Recall event | 91723 |
| Product | PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples |
| Product code | JJH |
| Recalling firm | Entopsis , Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3016994927 |
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