Date Initiated by Firm |
February 26, 2018 |
Create Date |
May 01, 2018 |
Recall Status1 |
Terminated 3 on May 12, 2020 |
Recall Number |
Z-1587-2018 |
Recall Event ID |
79683 |
510(K)Number |
K161954
|
Product Classification |
Clinical chemistry Electrode, ion specific, sodium - Product Code JGS
|
Product |
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens. |
Code Information |
UDI 00630414002439 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
Gene Victori 914-631-8000
|
Manufacturer Reason for Recall |
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
|
FDA Determined Cause 2 |
Software design |
Action |
Recall initiated 02/23/2018
Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally. |
Distribution |
FL
and
France
Spain
Sweden
United Kingdom
Germany |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JGS and Original Applicant = Siemens Healthcare Diagnostics
|