Date Initiated by Firm |
May 08, 2003 |
Date Posted |
May 29, 2003 |
Recall Status1 |
Terminated 3 on October 14, 2003 |
Recall Number |
Z-0872-03 |
Recall Event ID |
26292 |
510(K)Number |
k973743
|
Product Classification |
Radioimmunoassay, Estradiol - Product Code CHP
|
Product |
ACCESS Estradiol Reagent Test System |
Code Information |
Lot number 215173 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact |
Kathleen M Jaker 714-961-3666
|
Manufacturer Reason for Recall |
Short volume, resulting possibility of falsely elevated results.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit. |
Quantity in Commerce |
1593 kits |
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 = CHP and Original Applicant = BECKMAN INSTRUMENTS, INC.
|