Qiagen Sciences, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2577-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: May 18, 2018

Date Posted: August 15, 2018

Recall Number: Z-2577-2018

Event ID: 80404

Reason for Recall:

Potential for control line not appearing on the test strip

Status: Terminated

Product Quantity: 1620 kits

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

Distribution Pattern:

Worldwide - US Nationwide distribution an in the country of , Canada

Voluntary or Mandated:

Voluntary: Firm initiated