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U.S. Department of Health and Human Services

Class 2 Device Recall QIAGEN

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  Class 2 Device Recall QIAGEN see related information
Date Initiated by Firm January 28, 2020
Create Date March 12, 2020
Recall Status1 Completed
Recall Number Z-1476-2020
Recall Event ID 85004
510(K)Number K113319  
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
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)
Recalling Firm/
Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact SAME
Manufacturer 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
FDA Determined
Cause 2
Software change control
Action QIAGEN issued Urgent Medical Device Correction via email on 1/28/20 advising reason for recall, health risk and action to take: 1) Discontinue use of the Rotor-Gene Q instrument in the following specific conditions: ¿ The Rotor-Gene Q instrument is running Software 2.3.4 using the export function to LIMs 2) Upgrade to the latest version of the RGQ software which resolves the issue  version 2.3.5. This is expected to be available on 1st February 2020. Please visit the QIAGEN website to upgrade: www.qiagen.com/resources/resourcedetail?id=9d8bda8e-1fd7-4519-a1ff-b60bba526b57&lang=en. Apart from correcting this fault, no other changes to the software have been implemented. Laboratory personnel and clinicians are advised to consider a patients previous test results, other diagnostic tests, anamnesis and current clinical condition when interpreting results from this software. If the results do not match the patients clinical presentation, or incongruences are found with previous and concomitant tests or the results are otherwise unexpected, the patient sample should be retested using an alternate test method or a reference laboratory. 3) Complete the Acknowledgement of Receipt form and return it to QIAGEN. If you have further questions, please contact QIAGEN Technical Services Department on 800-362-7737 (US & Canada) " QIAGEN Subsidiaries: https://www.qiagen.com/about-us/contact/global-contacts/subsidiaries/ " QIAGEN Commercial Partners and Importers: https://www.qiagen.com/about-us/contact/global-contacts/distributors-and-importers/
Quantity in Commerce 11418 instruments
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = QIAGEN, GMBH