FDA recall Z-2577-2018

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-05-18

Report date

2018-08-15

Termination date

2020-09-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2018