Siemens ADVIA Chemistry Systems Recalled for Software Calibration Defect
Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is a software defect regarding automatic calibration, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Siemens ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400. These high-throughput instruments are used to perform assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring. The recall involves 3,759 units distributed worldwide and nationwide in the United States.
The recall is due to a software defect in specific versions of the ADVIA Chemistry software. The affected software allows the system to automatically run assay calibrations and quality control (QC). The affected software versions are ADVIA 1200 V2.00 and V2.01, ADVIA 1650 V3.52 and V4.01, ADVIA 1800 V2.01, and ADVIA 2400 V4.01.
Healthcare facilities and laboratories using these systems should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to resolve the software issue. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, m
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,759
Distribution
Distributed nationwide across the United States.
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