Recall Z-1476-2020 ยท OOI Real Time Nucleic Acid Amplification System
Qiagen Sciences LLC
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
| Date | Jan 28, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 co |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113319 | ROTOR-GENE Q MDX QIAGEN GmbH, Feb 6, 2012 |