Qiagen Sciences, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1891-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 6, 2019

Date Posted: July 3, 2019

Recall Number: Z-1891-2019

Event ID: 82985

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.

Status: Terminated

Product Quantity: 31

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.

Voluntary or Mandated:

Voluntary: Firm initiated