Recall Z-1891-2019— Qiagen Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences, Inc., initiated 2019-05-06, terminated 2020-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Qiagen Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-06
- Terminated
- 2020-04-23
- Firm location
- Germantown, MD, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.