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U.S. Department of Health and Human Services

Class 2 Device Recall RNeasy DSP FFPE Kit

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 Class 2 Device Recall RNeasy DSP FFPE Kitsee related information
Date Initiated by FirmMay 06, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on April 23, 2020
Recall NumberZ-1891-2019
Recall Event ID 82985
PMA NumberP180043 
Product Classification System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test - Product Code NTW
ProductRNeasy 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.
Code Information LOT 163016105
FEI Number 3003572099
Recalling Firm/
Manufacturer		 Qiagen Sciences, Inc.
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information ContactQIAGEN Technical Services
800-362-7737
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Notice of Product Field Action dated 5/6/19 were emailed to customers.
Quantity in Commerce31
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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