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U.S. Department of Health and Human Services

Class 2 Device Recall Access Folate WHO Calibrators

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  Class 2 Device Recall Access Folate WHO Calibrators see related information
Date Initiated by Firm July 24, 2012
Date Posted October 10, 2012
Recall Status1 Terminated 3 on October 17, 2013
Recall Number Z-0047-2013
Recall Event ID 63169
510(K)Number K111952  
Product Classification Calibrator, secondary - Product Code JIT
Product Access Folate WHO Calibrators, Part Number: A98033.

The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Code Information Lot# 122651, 123635, 219962
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated July 24, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to complete and return the enclosed Response Forms within 10 days. Customers with questions were instructed to call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter representative.
Quantity in Commerce 5,266 units total (3,214 units in US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.
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 = JIT and Original Applicant = BECKMAN COULTER, INC.
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