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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.

FDA Recall Z-1891-2019 · Posted None

Recalling FirmQiagen Sciences, Inc.
Recall StatusTerminated
Product CodeNTW
Date Initiated2019-05-06
Date Terminated2020-04-23
Product Quantity31

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.

Firm Action

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

Root Cause

Under Investigation by firm

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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