Qiagen Sciences, Inc. Recalls
Showing 1-2 of 2 recalls
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Potential for control line not appearing on the test strip
On May 18, 2018 QIAGEN issued Urgent Voluntary Medical Device Recall notices and response forms to customers. Customers were advised to take the following actions: 1) Immediately discontinue use of all impacted lots and return all unused product to QIAGEN. 2) Share the Voluntary Medical Device Recall Notice with all users of the AmniSure ROM Test in your facility to ensure they are aware of this recall. 3) Use the Return Response form to confirm receipt of the notification and to record quantity of material to return. If you have any questions regarding this notice, please contact Technical Services at 1-800-344-3631.
RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic
The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications.
Urgent Notice of Product Field Action dated 5/6/19 were emailed to customers.