Home / Recalls / Qiagen Sciences LLC / Z-1746-2022

Z-1746-2022 Class II Ongoing

Recalled by Qiagen Sciences LLC — Germantown, MD

Recall Details

Product Type
Devices
Report Date
September 21, 2022
Initiation Date
November 21, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
93 US; 57 OUS

Product Description

QIAcube Connect MDx, Model No. 9003070

Reason for Recall

During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

Distribution Pattern

Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.

Code Information

UDI-DI (GTIN): 04053228039129 Serial Numbers (U.S.) 30000 30009 30027 30039 30049 30061 30073 30002 30010 30028 30041 30050 30062 30075 30003 30132 30031 30042 30051 30063 30078 30004 30013 30032 30043 30053 30064 30080 30005 30016 30034 30044 30057 30065 30082 30006 30019 30035 30045 30058 30067 30089 30007 30021 30033 30046 30059 30069 30090 30008 30023 30037 30047 30060 30071 30093 30094 30095 30097 30102 30104 30109 30112 30114 30115 30117 30118 30119 30121 30124 30127 30128 30129 30130 30131 30133 30134 30136 30138 30139 30140 30141 30143 30145 30106 30025 30077 30054 30055 30066 30076

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-1650-2022 Class II — therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 (July 20, 2022)
  • 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-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-0455-2022 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69122 (November 8, 2021)