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FDA Import Refusal SCS-4840308-8/10002/1 — Qiagen GmbH

Qiagen GmbH — FEI 3004013603

The FDA refused shipment SCS-4840308-8/10002/1 from Qiagen GmbH (Germany) on October 9, 2025. The refused product falls under Devices — MULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2 AND OTHER MICROBIAL AGENTS. Cited charges: 3904,3905 This firm has 4 other import refusals on record.

Refusal Details

Date
October 9, 2025
Country
Germany
Product Category
Devices
Product Code
83QOF MULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2 AND OTHER MICROBIAL AGENTS
Charges
3904,3905

Recent inspections

  • 1314374 (NAI Thu Mar 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1197605 (VAI Fri Nov 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002815 (NAI Thu Feb 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945001 (NAI Thu Aug 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853200 (NAI Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-4559844-9/11/1 (Mon Jun 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • UPS-6474845-4/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-3583780-6/1/1 (Wed Nov 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0992756-6/1/1 (Mon Sep 30 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources