Recall StatusTerminated
Date Initiated2011-01-26
Date Terminated2012-05-04
Product Quantity3658 units (1800 in US)
Reason for Recall
The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin
Antibody II (TgAbII) reagent lots may produce:
(1) Erroneously high TgAb results for both quality co
Firm Action
Beckman Coulter sent a Product Corrective Action (PCA) letter on January 26, 2011 via US Postal Service to the affected customers. The letter explained the problem identified and the action to be taken.
Customers were instructed to:
(1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers identified in the table
above;
(2) If customers obtained questionable thyroglobulin antibody results, or received feedback from clinicians on reported thyroglobulin antibody results using the reagent lot numbers identified above, rerun or request a redraw of the patient sample;
(3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they should provide a copy of the letter to them;
(4) Complete and return the enclosed response form within 10 days so the firm can be assured that you have received this important notification and are taking appropriate action.
For questions regarding the recall communication, customers were told 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 representative.
Distribution Pattern
Worldwide Distribution - USA including AR, CA, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.