|
Class 2 Device Recall ARCHITECT Free T4 Calibrator Kit |
|
Date Initiated by Firm |
December 15, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on July 22, 2004 |
Recall Number |
Z-0353-04 |
Recall Event ID |
27977 |
510(K)Number |
K983417
|
Product Classification |
unknown device name - Product Code CEC--
|
Product |
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064 |
Code Information |
lots 94493M300 and 94493M301 |
Recalling Firm/ Manufacturer |
Abbott Laboratories HPD/ADD/GPRD 100/200 Abbott Park Road Abbott Park IL 60064
|
For Additional Information Contact |
Abbott Customer Service 877-422-2688
|
Manufacturer Reason for Recall |
The calibrator lots may yield Free T4 values that are depressed.
|
FDA Determined Cause 2 |
Other |
Action |
Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product. |
Quantity in Commerce |
1,364 kits |
Distribution |
Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan. |
|
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 = CEC-- and Original Applicant = ABBOTT LABORATORIES
|
|
|
|