Company: Roche Molecular Systems, Inc.
Date of Enforcement Report: 1/27/2021
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001.
Recall Number: Z-0883-2021
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
Roche Molecular Systems, Inc. on 12/17/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE