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Z-0780-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

FDA device recall Z-0780-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Sep 26, 2018 and is designated Class II. Reason for recall: Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler… The recall status is terminated (terminated Jun 24, 2020). Affected quantity: 217 units.

Recall Details

Product Type: Devices
Report Date: Feb 6, 2019
Initiation Date: Sep 26, 2018
Termination Date: Jun 24, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 217 units

Product Description

Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Reason for Recall

Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime

Distribution Pattern

Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, U.A.E., United Kingdom, Vietnam.

Code Information

Software in V 1.14.2 and lower.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0780-2019
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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