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U.S. Department of Health and Human Services

Class 2 Device Recall Access 2 Immunoassay System

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 Class 2 Recall
Access 2 Immunoassay System
see related information
Date Posted November 14, 2013
Recall Status1 Terminated on November 14, 2013
Recall Number Z-0291-2014
Recall Event ID 66397
Premarket Notification
510(K) Number
K922823 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Access 2 Immunoassay System, Part Number: 81600N 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 Serial Numbers: 508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact Dung Nguyen
714-961-4941
Manufacturer Reason
for Recall
Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action A phone call was made on 9/12/13 to customer who received the Access 2 System. The phone script explains the problem identified of a possible wrong fuse and may result in failure of the fuse to operate properly. Customer was instructed that their Field Service Engineer, will call them back the following week to check on their system and replace the fuses if necessary. If you have any questions concerning this information, please call 952-393-8546.
Quantity in Commerce 8 units total (1 unit in the US)
Distribution Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
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