Date Initiated by Firm |
December 29, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on February 20, 2004 |
Recall Number |
Z-0329-04 |
Recall Event ID |
27989 |
510(K)Number |
K945915
|
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
Product |
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-526-2272
|
Manufacturer Reason for Recall |
The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
|
FDA Determined Cause 2 |
Other |
Action |
A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types. |
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 = AVL SCIENTIFIC CORP.
|