FDA-Device2019-05-29Class II
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
Hazard
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Sold states
US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
Affected count
15 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2019Don't want to check this manually?
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