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.
Enforcement
- Recall Number
- Z-1891-2019
- Event ID
- 82985
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Qiagen Sciences, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 3, 2019
- Initiation Date
- May 6, 2019
- Classification Date
- June 27, 2019
- Termination Date
- April 23, 2020
- Address
- 19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States
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.
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.
LOT 163016105
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.
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