Qiagen Sciences LLC recalls AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distributi
Recalled 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)
Hazard / Issue
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Issued by
FDA
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