FDAFDA · Food and drugs·Recall number Z-0940-2014
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, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Published February 19, 2014 · Recall initiated: November 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution and USA Nationwide.
- Lot
- ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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