Date Initiated by Firm |
November 26, 2013 |
Date Posted |
February 16, 2014 |
Recall Status1 |
Terminated 3 on July 27, 2014 |
Recall Number |
Z-0984-2014 |
Recall Event ID |
66958 |
510(K)Number |
K922823
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
Access 2 Immunoassay System Analyzer.
The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. |
Code Information |
Part Number 81600N. Serial Numbers 508957, 508963, 508964. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
|
Manufacturer Reason for Recall |
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information. |
Quantity in Commerce |
3 units |
Distribution |
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China. |
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.
|