Recall Z-1636-2020— Qiagen Sciences LLC

Name: FDA recall Z-1636-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Class II · Terminated

Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2020-02-21, terminated 2020-10-05. It names one FDA 510(k) clearance: K081767. 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: An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute..

Recalling firm: Qiagen Sciences LLC
Classification: Class II
Status: Terminated
Initiated: 2020-02-21
Terminated: 2020-10-05
Firm location: Germantown, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K081767 — AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1Amnisure International, LLC·cleared 2009-01-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.