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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems

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  Class 2 Device Recall Access Immunoassay Systems see related information
Date Initiated by Firm April 15, 2011
Date Posted January 30, 2012
Recall Status1 Terminated 3 on December 21, 2012
Recall Number Z-3126-2011
Recall Event ID 58719
510(K)Number K922823  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Access Immunoassay Systems Part Number: 81600
Access 2 Immunoassay Systems Part Number: 81600N
Access Immunoassay Systems LXi 725 Part Number: 386200

Subsequent Product Codes: JGS

The Access/DxI 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 All Serial Numbers
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i
FDA Determined
Cause 2		 Other
Action Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.
Quantity in Commerce 11,266 units
Distribution Worldwide Distribution--USA (nationwide) and Puerto Rico and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayette, Mexico, Morocco, Nambia, Netherlands, New Zealand, Norway, Philippines, Poland,, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela and Vietnam.
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.
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