FDA recall Z-1636-2020

Product

AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)

Reason for recall

An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

Distribution

Nationwide domestic distribution. Foreign distribution to Canada.

Key facts

Status

Terminated

Initiation date

2020-02-21

Report date

2020-04-08

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germantown, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2020