Date Initiated by Firm |
February 20, 2003 |
Date Posted |
April 02, 2003 |
Recall Status1 |
Terminated 3 on September 25, 2003 |
Recall Number |
Z-0706-03 |
Recall Event ID |
25741 |
510(K)Number |
K993203
|
Product Classification |
Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
|
Product |
ICON DS hCG, an in-vitro diagnostic. Part number 44025. |
Code Information |
Lot numbers hCG010401, hCG010704, hCG010902 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact |
Kathleen Jaker 714-961-3626
|
Manufacturer Reason for Recall |
Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
|
FDA Determined Cause 2 |
Other |
Action |
Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product. |
Quantity in Commerce |
12,804 |
Distribution |
Nationwide and Canada. |
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 = JHI and Original Applicant = ACON LABORATORIES, INC.
|