Date Initiated by Firm | May 20, 2013 |
Date Posted | December 02, 2013 |
Recall Status1 |
Terminated 3 on April 10, 2014 |
Recall Number | Z-0430-2014 |
Recall Event ID |
65408 |
510(K)Number | K051087 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1.
Diagnostic device intended to determine a variety of analytes in human body fluids. |
Code Information |
Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801 |
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 800-441-9250 |
Manufacturer Reason for Recall | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1 |
FDA Determined Cause 2 | Software design |
Action | A notification letter was sent to consignees in May 2013. |
Quantity in Commerce | 776 |
Distribution | Worldwide Distribution: USA (nationwide) and iinternationally to Canada. |
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
|