Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 1/20/2021
Class II
PRODUCT
Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Recall Number: Z-0861-2021
REASON
Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. on 12/2/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2405 units
DISTRIBUTION
U.S. Nationwide and International