Class II — Qiagen Sciences, Inc.
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 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. |
| Initiated | 2019-05-06 |
| Classified | 2019-06-27 |
| Terminated | 2020-04-23 |
| Recall number | Z-1891-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qiagen Sciences, Inc. (Z-1891-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82985/
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