Date Initiated by Firm |
May 28, 2004 |
Date Posted |
July 28, 2004 |
Recall Status1 |
Terminated 3 on September 10, 2004 |
Recall Number |
Z-1229-04 |
Recall Event ID |
29289 |
510(K)Number |
K874485
|
Product Classification |
Enzyme Immunoassay, Opiates - Product Code DJG
|
Product |
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
|
Code Information |
Lot/Unit numbers Exp. date 10750Q100 9/22/04 09650Q100 9/15/04 |
Recalling Firm/ Manufacturer |
Abbott Health Products, Inc. Hwy 2 Km 58.0 Barceloneta PR 00617
|
For Additional Information Contact |
Nydia I. Cancel 787-846-8256
|
Manufacturer Reason for Recall |
Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
|
FDA Determined Cause 2 |
Other |
Action |
A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
|
Quantity in Commerce |
941 kits |
Distribution |
Distribution was to hospitals/laboratories |
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 = DJG and Original Applicant = ABBOTT LABORATORIES
|