Recall Z-1476-2020

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: Software change control

Action taken

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/