Date Initiated by Firm | February 27, 2013 |
Date Posted | April 01, 2013 |
Recall Status1 |
Terminated 3 on January 14, 2014 |
Recall Number | Z-1047-2013 |
Recall Event ID |
64570 |
510(K)Number | K073604 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377).
Intended to measure a variety of analytes in human body fluids. |
Code Information |
Siemens Material Number 106393377 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
|
For Additional Information Contact | Customer Support 302-631-6311 |
Manufacturer Reason for Recall | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers. |
Quantity in Commerce | 2207 total |
Distribution | Worldwide Distribution. |
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 = JJE
|