Rotor-Gene Q Software (2020-02-03)

Starting date:

February 3, 2020

Posting date:

April 15, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72735

Last updated: 2020-04-15

• Reason
• Affected products

Affected Products

Rotor-Gene Q Software

Reason

RGQ SW version 2.3.4 completing a lims export, the .CSV file reports the calculated concentration result value as a logarithmic value. For quantitative analysis there is a risk that results will be significantly under the expected value and reflected in the lims system could lead to a false negative result.

Affected products