Device recall
Z-1298-2023: PCRopsis Lysis Beads, IVDD: a) 25 tubes, REF 597000; b) 25 tubes, REF 597825…
FDA device recall · Class II · Entopsis, Inc.
Key facts
| Recall number (Z-number) | Z-1298-2023 |
|---|---|
| Recall event | 91723 |
| Product | PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; 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