medical Class II Updated 2020-04-08

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

Distribution: Nationwide (United States)
Lot/Code Info: FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195
View official government recall

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