Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 12/12/2021
Class II
PRODUCT
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
Recall Number: Z-0449-2022
REASON
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 11/18/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
2,980 units
DISTRIBUTION
U.S. Nationwide and International