Kit Cobas 6800/8800 Sars-Cov-2/Flu
Brand(s)
Summary
Contact Roche Diagnostics if you require additional information.
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
Roche Molecular Systems, Inc
1080 Us Highway 202 South, Branchburg, New Jersey, United States, 08876
Get notified
Receive notifications for new and updated recalls and alerts by category.