{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Germantown",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85004",
      "recalling_firm": "Qiagen Sciences LLC",
      "address_1": "19300 Germantown Rd",
      "address_2": "",
      "postal_code": "20874-1415",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "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.",
      "recall_number": "Z-1476-2020",
      "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.",
      "product_quantity": "11418 instruments",
      "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",
      "recall_initiation_date": "20200128",
      "center_classification_date": "20200312",
      "termination_date": "20240926",
      "report_date": "20200318",
      "code_info": "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)",
      "more_code_info": ""
    }
  ]
}