Class 2 Device Recall Access Total T4 Reagent Kit

• Date Initiated by Firm: March 10, 2011
• Date Posted: April 12, 2011
• Recall Status: Terminated on August 10, 2012
• Recall Number: Z-1949-2011
• Recall Event ID: 58169
• 510(K)Number: K926475 K023369
• Product Classification: Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
• Product: Access Total T4 Reagent Kit, Part Number: 33800, ; Lot Numbers (s): All reagent pack lots; ; The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
• Code Information: Lot Numbers (s): All reagent pack lots
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. ODonovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm
• FDA Determined Cause: Other
• Action: Beckman Coulter sent an Urgent Product Correction letter dated March 20, 2011, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignees were issued the following instructions: (1) If you suspect pregnant patient results were evaluated at your laboratory using only Total T4 to report thyroid status, consider reviewing Total T4 results reported in the last 9 months. Consult with your Laboratory Medical Director and requesting physician to resolve any concerns you may have regarding previously reported patient results during this time period. (2) Do not use the Access Total T4 assay as the only marker for evaluating pregnant patients for thyroid disorders. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded Access Total T4 reagent kits (Part Number 33800) to another laboratory, please provide a copy of this letter to them. (4) Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. For questions regarding this notice, consignees were instructed to contact Beckman Coulter Customer Support Center. (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter
• Quantity in Commerce: 151,740 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, 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 = KLI and Original Applicant = BECKMAN COULTER, INC.; 510(K)s with Product Code = KLI and Original Applicant = BIO-RAD LABORATORIES, INC.