Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 5/7/2020
Class II
PRODUCT
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Recall Number: Z-1797-2020
REASON
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 2/27/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1807
DISTRIBUTION
US Nationwide and International