Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0940-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 6, 2013

Date Posted: February 19, 2014

Recall Number: Z-0940-2014

Event ID: 67027

Reason for Recall:

The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).

Status: Terminated

Product Quantity: 3759

Code Information:

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

Distribution Pattern:

Worldwide Distribution and USA Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated