Date Initiated by Firm |
August 06, 2004 |
Date Posted |
September 02, 2004 |
Recall Status1 |
Terminated 3 on June 26, 2006 |
Recall Number |
Z-1432-04 |
Recall Event ID |
29648 |
510(K)Number |
K901003
|
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
Product |
Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
Technical Support 800-428-2336
|
Manufacturer Reason for Recall |
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it. |
Distribution |
United States. |
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 and Original Applicant = BOEHRINGER MANNHEIM CORP.
|