Z-1891-2019Class II

RNeasy DSP FFPE Kit (48), REF 73604 -

Name: Z-1891-2019 RNeasy DSP FFPE Kit (48), REF 73604 -
Creator: Qiagen Sciences, Inc.
Published: 2019-05-06
License: https://open.fda.gov/license/

Qiagen / initiated 2019-05-06 / Terminated

FDA source

Qiagen Sciences, Inc. began a recall of 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... on 2019-05-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1891-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-06
Posted: 2019-06-28
Terminated: 2020-04-23
Recalling firm: Qiagen
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.
Product code: NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
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 root cause: Under Investigation by firm
Action: Urgent Notice of Product Field Action dated 5/6/19 were emailed to customers.
Quantity in commerce: 31
Distribution: 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.
Product codes and lots: LOT 163016105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1891-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1891-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-27

Product code NTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)