Home / Recalls / Qiagen Sciences LLC / Z-1476-2020

Z-1476-2020 Class II Terminated

Recalled by Qiagen Sciences LLC — Germantown, MD

FDA device recall Z-1476-2020 was initiated by Qiagen Sciences LLC on January 28, 2020 and is designated Class II. Reason for recall: When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false neg… The recall status is terminated (terminated September 26, 2024). Affected quantity: 11418 instruments.

Recall Details

Product Type
Devices
Report Date
March 18, 2020
Initiation Date
January 28, 2020
Termination Date
September 26, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11418 instruments

Product Description

QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

Reason for Recall

When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment

Distribution Pattern

Worldwide distribution - US Nationwide distribution and countries Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macao, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mayotte, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory Occupied, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab, Republic of Taiwan, Tajikistan, Thailand, Timor-Leste (else known as East Timor), Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic of, Viet Nam, Yemen.

Code Information

Software version 2.3.4 used in the following: Product No. / Description 9001680 Rotor-Gene Q 2Plex no PC 9001680R Rotor-Gene Q 2Plex no PC refurbished 9001690 Rotor-Gene Q 2Plex HRM no PC 9001690R Rotor-Gene Q 2Plex HRM no PC refurbished 9001700 Rotor-Gene Q 5Plex no PC 9001700R Rotor-Gene Q 5Plex no PC refurbished 9001710 Rotor-Gene Q 5Plex HRM no PC 9001710R Rotor-Gene Q 5Plex HRM no PC refurbished 9001720 Rotor-Gene Q 6Plex no PC 9001720R Rotor-Gene Q 6Plex no PC refurbished 9001960 Rotor-Gene AusDx (Outback Red) 9002000 Rotor-Gene Q MDx 2Plex 9002001 Rotor-Gene Q MDx 2Plex no PC 9002010 Rotor-Gene Q MDx 2Plex HRM 9002011 #Rotor-Gene Q MDx 2Plex HRM no PC 9002020 Rotor-Gene Q MDx 5Plex 9002021 Rotor-Gene Q MDx 5Plex no PC 9002029 Rotor-Gene Q MDx 5plex, PrioPLUS 9002030 Rotor-Gene Q MDx 5Plex HRM 9002030R Rotor-Gene Q MDx 5Plex HRM refurbished 9002031 Rotor-Gene Q MDx 5Plex HRM no PC 9002040 Rotor-Gene Q MDx 6Plex 9002041 Rotor-Gene Q MDx 6Plex no PC90275010 9002204 Rotor-Gene Q DBV 9023241 Rotor-Gene Q Software 9002370 5 plex MDx HRM with laptop (canada) This issue can affect the following QIAGEN IVD kits: Catalogue number Product Name 4514363 artus BK Virus QS-RGQ Kit (24) 4514263 artus BK Virus RG PCR Kit (24) 4514265 artus BK Virus RG PCR Kit (96) 4503363 artus CMV QS-RGQ Kit (24) 4503263 artus CMV RG PCR Kit (24) 4503265 artus CMV RG PCR Kit (96) 4501363 artus EBV QS-RGQ Kit (24) 4501263 artus EBV RG PCR Kit (24) 4501265 artus EBV RG PCR Kit (96) 4506366 artus HBV QS-RGQ (72) 4506356 artus HBV QS-RGQ Kit (24) 4506363 artus HBV QS-RGQ Kit (24) 4506263 artus HBV RG PCR Kit (24) 4506265 artus HBV RG PCR Kit (96) 4518356 artus HCV QS-RGQ Kit (24) 4518363 artus HCV QS-RGQ Kit (24) 4518366 artus HCV QS-RGQ Kit (72) 4538366 artus HCV QS-RGQ Kit V2 4518253 artus HCV RG RT-PCR Kit (24) 4518263 artus HCV RG RT-PCR Kit (24) 4518265 artus HCV RG RT-PCR Kit (96) 4513363 artus HI Virus-1 QS-RGQ Kit (24) 4513366 artus HI Virus-1 QS-RGQ Kit (72) 4513253 artus HI Virus-1 RG RT-PCR Kit (24) 4513263 artus HI Virus-1 RG RT-PCR Kit (24) 4513265 artus HI Virus-1 RG RT-PCR Kit (96) 4502363 artus VZV QS-RGQ Kit (24) 4502263 artus VZV RG PCR Kit (24) 4502265 artus VZV RG PCR Kit (96) 4532265 artus JCV RG PCR Kit (96) 4555263 artus M.tuberculosis RG PCR Kit (24) 4555265 artus M.tuberculosis RG PCR Kit (96) 4504263 artus Parvo B19 RG PCR Kit (24) 4511263 artus SARS RG RT-PCR Kit (24)

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-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-1651-2022 Class II — therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 (July 20, 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-0951-2022 Class II — therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) (February 25, 2022)
  • Z-1746-2022 Class II — QIAcube Connect MDx, Model No. 9003070 (November 21, 2021)

FDA data resources