Class 2 Device Recall Access Free T3

• Date Initiated by Firm: June 08, 2016
• Date Posted: June 30, 2016
• Recall Status: Terminated on April 18, 2017
• Recall Number: Z-2108-2016
• Recall Event ID: 74393
• Product Classification: Radioimmunoassay, total triiodothyronine - Product Code CDP
• Product: Access Free T3 Assay, Ref No. A13422; ; The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
• Code Information: 524087 526807 528874 529913 530102 531647 532473 534080 534081 534336 535481 570090 570116 570222 570236 570239 570245 570246 622173 622174 671016 671025 671033
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Mark Price; 714-961-4933
• Manufacturer Reason for Recall: Demonstrate an upward shift in patient results.
• FDA Determined Cause: Device Design
• Action: Beckman Coulter sent an " Urgent Medical Device Recall" letter dated June 8, 2016, to all affected customers. Beckman Coulter has determined through customer feedback and internal testing that the Access Free T3 Reagent lots listed above demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots. The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center at http:www.beckmancoulter.com, call (800) 854-3633 in US and Canada. Customers outside US and Canada, are instructed to contact local Beckman Coulter representative.
• Quantity in Commerce: 205,744 kits total (13,358 kits in US)
• Distribution: Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, 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, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, 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.