Recall – Chemistry analyzer parameters may inadvertently revert

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

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