FDA-Device2020-02-19Class II
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Roche Diagnostics Operations, Inc.
Hazard
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Sold states
Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
Affected count
26 accounts
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2020Don't want to check this manually?
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