FDA-Device2021-09-22Class II
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche Diagnostics Operations, Inc.
Hazard
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
Sold states
US Nationwide distribution
Affected count
2058 licenses worldwide, 79 licenses in US
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2444-2021Don't want to check this manually?
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