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U.S. Department of Health and Human Services

Class 2 Device Recall Access hLH Calibrators

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 Class 2 Recall
Access hLH Calibrators
see related information
Date Posted December 20, 2012
Recall Status1 Terminated on May 14, 2014
Recall Number Z-0572-2013
Recall Event ID 63784
Premarket Notification
510(K) Number
K940549 
Product Classification Radioimmunoassay, Luteinizing Hormone - Product Code CEP
Product The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
Code Information Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
Manufacturer Reason
for Recall
Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Beckman Coulter Inc. (BEC) sent an "URGENT FIELD SAFETY NOTICE" dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these the affected lots did not meet BEC's procedural requirements for a 12-month shelf-life claim. Contact the firm at 952-448-4848 for assistance with this recall.
Quantity in Commerce 14409
Distribution Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Moldova Republic, Morocco, Myanmar, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe
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 = CEP and Original Applicant = BIO-RAD LABORATORIES, INC.
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