Device 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.
Z-1891-2019
Product summary
- Event
- Event 82985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-1891-2019
Official wording
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.
Code information: LOT 163016105
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.