Device recall
Z-1636-2020: AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)…
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-1636-2020 |
|---|---|
| Recall event | 85122 |
| Product | AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box) |
| Product code | NQM |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K081767 |
| FEI number | 3003572099 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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