AmniSure ROM Test — Class II medical device recall Z-1636-2020
Terminated recall by Qiagen Sciences LLC, reported 2020-04-08, distributed nationwide. An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse
| Recall number | Z-1636-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2020-02-21 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,654 kits |
| Lot numbers | 563010976, 563011164, 563011195, 563011618, 563011620, 5660397, 5660552, FMRT-1-10-US, FMRT-1-25-CA |
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 for recall
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1636-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.