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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems Estradiol

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  Class 2 Device Recall Access Immunoassay Systems Estradiol see related information
Date Initiated by Firm March 04, 2010
Date Posted November 23, 2010
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-0448-2011
Recall Event ID 55200
510(K)Number K973743  
Product Classification radioimmunoassay, estradiol - Product Code CHP
Product Access Immunoassay Systems Estradiol, Part Number: 33540
Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.
Code Information Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)
Recalling Firm/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
Manufacturer Reason
for Recall
The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.
FDA Determined
Cause 2
Action A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. The following product replacement contacts were provided: In the United States, please contact Client Services at 1-800-526-3821. In Canada, please contact Customer Service at 1-800-463-7828. Outside the United States and Canada, contact your local Beckman Coulter Representative. Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.
Quantity in Commerce 20,209 units (5475 in US)
Distribution Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia
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 = CHP and Original Applicant = BECKMAN INSTRUMENTS, INC.