Health product recall

Kit Cobas 6800/8800 Sars-Cov-2/Flu

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 09446125190

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:
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

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