FDA Device recall Z-1636-2020
AmniSure ROM Test, Material Nos
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of AmniSure ROM Test, Material Nos by Qiagen Sciences, citing an image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1636-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-21 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
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)
Reason
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Identifiers
| code_info | FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.