Home / Recalls / Qiagen Sciences LLC / Z-2088-2019

Z-2088-2019 Class I Terminated

Recalled by Qiagen Sciences LLC — Germantown, MD

Recall Details

Product Type
Devices
Report Date
August 7, 2019
Initiation Date
June 5, 2019
Termination Date
August 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1240 Kits

Product Description

Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

Reason for Recall

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

Distribution Pattern

US Nationwide distribution

Code Information

Lot Numbers: 0605020019 and 0605020020

Other recalls by Qiagen Sciences LLC

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  • Z-1508-2024 Class II — EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of (March 4, 2024)
  • Z-1683-2023 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR t (April 28, 2023)
  • Z-1651-2022 Class II — therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 (July 20, 2022)
  • Z-1652-2022 Class II — FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 (July 20, 2022)
  • Z-1650-2022 Class II — therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 (July 20, 2022)
  • Z-0951-2022 Class II — therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) (February 25, 2022)
  • Z-0952-2022 Class II — therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the US (February 25, 2022)
  • Z-1746-2022 Class II — QIAcube Connect MDx, Model No. 9003070 (November 21, 2021)