FDA-Device2016-07-27Class II

cobas¿ Liat¿ Analyzer

Roche Molecular Systems, Inc.
Hazard

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

Sold states
Distributed in NC and WA.
Affected count
2
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas¿ Liat¿ Analyzer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2216-2016

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