Siemens Healthcare Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-0344-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs 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: September 3, 2013

Date Posted: November 27, 2013

Recall Number: Z-0344-2014

Event ID: 66069

Reason for Recall:

Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.

Status: Terminated

Product Quantity: 892 units

Code Information:

Product Codes: 1) 10318424, 2) 10285281

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated