Qiagen Sciences LLC: Medical Device Recall in 2020 - (Recall #: Z-1636-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: February 21, 2020

Date Posted: April 8, 2020

Recall Number: Z-1636-2020

Event ID: 85122

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.

Status: Terminated

Product Quantity: 1654 kit boxes

Code Information:

FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195

Distribution Pattern:

Nationwide domestic distribution. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated