Kit Cobas 6800/8800 Sars-Cov-2/Flu
Brand(s)
Last updated
Summary
Product
Kit Cobas 6800/8800 Sars-Cov-2/Flu
Issue
Medical devices - Performance issue
What to do
Contact Roche Diagnostics if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Kit Cobas 6800/8800 Sars-Cov-2/Flu |
All lots. |
09233474190 |
Issue
Roche received customer complaints alleging the generation of false negative influenza a (flu a) results and late flu a target CT values when using the Cobas® Cars-Cov-2 & influenza a/b qualitative for use on Cobas® 6800/8800 systems. These allegations are specific to recently circulating mutations (single or double mutation) in h1n1pdm09 pertinent to the region of interest of the aforementioned test.
Recall start date: December 22, 2022
Additional information
Details
Original published date: 2023-01-05
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
Roche Molecular Systems, Inc
1080 Us Highway 202 South, Branchburg, New Jersey, United States, 08876
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72530