Jan

2021

Recall – IVD analyzer software errors may result in incorrect patient results

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

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Recall – IVD analyzer software errors may result in incorrect patient results

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