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
|