Device recall
Z-1299-2023: PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF…
FDA device recall · Class II · Entopsis, Inc.
Key facts
| Recall number (Z-number) | Z-1299-2023 |
|---|---|
| Recall event | 91723 |
| Product | PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, 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