Date Initiated by Firm |
January 27, 2003 |
Date Posted |
March 06, 2003 |
Recall Status1 |
Terminated 3 on October 08, 2003 |
Recall Number |
Z-0619-03 |
Recall Event ID |
25482 |
510(K)Number |
K922823
|
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
Product |
Access and Access 2 Immunoassay Systems
862.2160 Discrete photometric chemistry analyzer for clinical use. |
Code Information |
Not applicable. |
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 |
Spring failure, design defect in component.
|
FDA Determined Cause 2 |
Other |
Action |
A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment) |
Quantity in Commerce |
2418 |
Distribution |
Product has been distributed in US from 8/92 to present. All these units are affected. |
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 = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
|