AmniSure ROM Test under the following labels: 1) Catalog Number… — Class I medical device recall Z-2577-2018
Terminated recall by Qiagen Sciences, Inc., reported 2018-08-15, distributed nationwide. Potential for control line not appearing on the test strip
| Recall number | Z-2577-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences, Inc., Germantown, MD, United States |
| Recall initiated | 2018-05-18 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,620 kits |
| UPC / GTIN / UDI-DI | 14053228022319, 14053228022333 |
| Lot numbers | 557016409, 557016546, 557016547, 5600115 |
| Model numbers | FMRT-1-25, FMRT-1-25-CA |
| Expiration dates | 2020-07-28 |
Product
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Reason for recall
Potential for control line not appearing on the test strip
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-2577-2018. 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.