Recall Z-2577-2018— Qiagen Sciences, Inc.

Name: FDA recall Z-2577-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-18

Class I · Terminated

Class I FDA medical device recall by Qiagen Sciences, Inc., initiated 2018-05-18, terminated 2020-09-02. It names one FDA 510(k) clearance: K081767. 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: Potential for control line not appearing on the test strip.

Recalling firm: Qiagen Sciences, Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-05-18
Terminated: 2020-09-02
Firm location: Germantown, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K081767 — AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1Amnisure International, LLC·cleared 2009-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.