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Roche Diagnostics Operations, Inc. recalls cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Recalled September 22, 2021 · FDA recall Z-2444-2021 · Roche Diagnostics Operations
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. · FDA Class II
Units
2058 licenses worldwide, 79 licenses in US
Sold at
US Nationwide distribution
Description
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.
Product
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →