FDA-Device2013-05-29Class II
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Roche Molecular Systems, Inc.
Hazard
In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
Sold states
Nationwide Distribution.
Affected count
425 instruments
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2013Don't want to check this manually?
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