Home / Recalls / Qiagen Sciences LLC / Z-1683-2023

Z-1683-2023 Class II Ongoing

Recalled by Qiagen Sciences LLC — Germantown, MD

Recall Details

Product Type
Devices
Report Date
June 14, 2023
Initiation Date
April 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
347 kits

Product Description

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

Reason for Recall

Faulty cartridges in the lot could result in false test results.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

Code Information

GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

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-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)
  • Z-0455-2022 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69122 (November 8, 2021)