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U.S. Department of Health and Human Services

Class 2 Device Recall Manual Inhibin A ELISA Reagent Kit; Part Number DSL10281001

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  Class 2 Device Recall Manual Inhibin A ELISA Reagent Kit; Part Number DSL10281001 see related information
Date Initiated by Firm March 31, 2011
Date Posted July 11, 2011
Recall Status1 Terminated 3 on July 11, 2012
Recall Number Z-2772-2011
Recall Event ID 58720
510(K)Number K002128  
Product Classification Inhibin-A Immunoassay - Product Code ndr
Product Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1

The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Code Information Lot Number: 992220, 992487, 992721, 992737, 091054, 091172, 091077, 090495   
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results may lead to unnecessary ultrasound testing to confirm gestational age, patient psychological stress until diagnostic testing is completed, and/or medical decis
FDA Determined
Cause 2		 Process design
Action Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers. The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return. For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter representative.
Quantity in Commerce 5521 units total for all products
Distribution Worldwide distribution: (USA) Nationwide and the countries of Armenia, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Peru, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
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 = ndr and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.
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