Z-2577-2018 Class I Terminated
FDA device recall Z-2577-2018 was initiated by Qiagen Sciences, Inc. on May 18, 2018 and is designated Class I. Reason for recall: Potential for control line not appearing on the test strip The recall status is terminated (terminated Sep 2, 2020). Affected quantity: 1620 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 15, 2018
- Initiation Date
- May 18, 2018
- Termination Date
- Sep 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1620 kits
Product Description
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
Distribution Pattern
Worldwide - US Nationwide distribution an in the country of , Canada
Code Information
1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2577-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026