Date Initiated by Firm |
December 06, 2002 |
Date Posted |
January 30, 2003 |
Recall Status1 |
Terminated 3 on July 26, 2003 |
Recall Number |
Z-0494-03 |
Recall Event ID |
25392 |
510(K)Number |
K955769
|
Product Classification |
Radioimmunoassay, Progesterone - Product Code JLS
|
Product |
Access Progesterone Assay, Part number 33550.
|
Code Information |
All Lots. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact |
Lynne McBride 714-961-3626
|
Manufacturer Reason for Recall |
Primary tube sampling issue may cause false low results.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem. |
Quantity in Commerce |
6,655 |
Distribution |
USA 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 = JLS and Original Applicant = BIO-RAD LABORATORIES, INC.
|