Recall Z-0344-2014— Siemens Healthcare Diagnostics

Name: FDA recall Z-0344-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-03

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2013-09-03, terminated 2017-03-07. It names one FDA 510(k) clearance: K990346. Product: 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-09-03
Terminated: 2017-03-07
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.·cleared 1999-05-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.