Date Initiated by Firm |
February 26, 2013 |
Date Posted |
May 04, 2014 |
Recall Status1 |
Terminated 3 on May 06, 2014 |
Recall Number |
Z-1545-2014 |
Recall Event ID |
67930 |
510(K)Number |
K091216
|
Product Classification |
Automated urinalysis system - Product Code KQO
|
Product |
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. |
Code Information |
Serial Number: 212809 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Drive Norwood MA 02062
|
For Additional Information Contact |
781-269-3000
|
Manufacturer Reason for Recall |
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
|
FDA Determined Cause 2 |
Reprocessing Controls |
Action |
On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument. |
Quantity in Commerce |
1 unit |
Distribution |
US Distribution in the state of: CA. |
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 = KQO and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
|