Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of QIAGENLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Qiagen Sciences with 23 device recalls. The most recent is a device recall dated May 6, 2019: RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 6, 2019 | 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 forClass II · The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resu | Device recalls |
| May 18, 2018 | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-iClass I · Potential for control line not appearing on the test strip | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
