ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein me

FDA device recall Z-0346-2014 · posted 2013-11-18 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

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.

Action taken

On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).

Root cause

Software design

Status

Terminated

Product code

JGS

Quantity affected

876 units

Distribution

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

Date initiated

2013-09-03

Date posted

2013-11-18

Date terminated

2017-03-07

Location

Tarrytown, NY