RNeasy DSP FFPE Kit — Class II medical device recall Z-1891-2019
Terminated recall by Qiagen Sciences, Inc., reported 2019-07-03, distributed nationwide. The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected
| Recall number | Z-1891-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences, Inc., Germantown, MD, United States |
| Recall initiated | 2019-05-06 |
| Classified | 2019-06-27 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, FR, GB, IT, SE |
| Quantity | 31 |
| Lot numbers | 163016105 |
| Model numbers | 73604 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1891-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.