Recalls / —

—#97800

Product

Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

FDA product code

JNL — Immunochemical, Thyroglobulin Autoantibody

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K062516

Affected lot / code info

Lot Number:  012741, 014751, 016551, 016838

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc.

Address

200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

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

Timeline

Recall initiated

2011-01-26

Posted by FDA

2011-03-24

Terminated

2012-05-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #97800. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.