Date Initiated by Firm |
December 03, 2004 |
Date Posted |
January 06, 2005 |
Recall Status1 |
Terminated 3 on September 08, 2005 |
Recall Number |
Z-0383-05 |
Recall Event ID |
30563 |
510(K)Number |
K000784
|
Product |
Roche brand Cardiac Reader. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-428-2336
|
Manufacturer Reason for Recall |
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
|
FDA Determined Cause 2 |
Other |
Action |
User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device. The firm issued a press release on December 8, 2004. |
Quantity in Commerce |
95 |
Distribution |
United States. |
|
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 = and Original Applicant = ROCHE DIAGNOSTICS CORP.
|