FDA Recall Terminated

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 use.

Recall: Z-1891-2019 · Initiated May 6, 2019

Recall

Recall Number
Z-1891-2019
Event Number
82985
Firm
Qiagen Sciences, Inc.
FEI Number
3003572099
Product Code
NTW
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
May 6, 2019
Terminated
April 23, 2020
Address
19300 Germantown Rd, Germantown, MD, 20874-1415

Description

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 use.

Reason

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.

Action

Urgent Notice of Product Field Action dated 5/6/19 were emailed to customers.

Distribution

US nationwide distribution in the states of MA, RI, AZ, NY, NC, IN, TX. The products were distributed to the following foreign countries: Germany, Great Britain, Italy, France, Sweden, and Switzerland.

Quantity

31