Home / Recalls / Qiagen Sciences LLC / Z-0455-2022

Z-0455-2022 Class II Terminated

Recalled by Qiagen Sciences LLC — Germantown, MD

Recall Details

Product Type
Devices
Report Date
January 12, 2022
Initiation Date
November 8, 2021
Termination Date
March 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
376 kits

Product Description

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

Reason for Recall

The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

Distribution Pattern

Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.

Code Information

LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567

Other recalls by Qiagen Sciences LLC

  • Z-1504-2025 Class II — Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Referen (March 12, 2025)
  • Z-2353-2024 Class II — QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and (June 3, 2024)
  • 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)