Terminated

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

FDA Recall Z-1476-2020 · Posted None

Recalling FirmQiagen Sciences LLC

Recall StatusTerminated

Product CodeOOI

Date Initiated2020-01-28

Date Terminated2024-09-26

Product Quantity11418 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

Firm 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/

Root Cause

Software change control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113319ROTOR-GENE Q MDXQIAGEN GmbH · 2012-02-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.