—#92965

Product

Beckman Coulter Access Thyroglobulin Antibody II Reagent, 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 Numbers: 917073, 918433 & 916271

Why it was recalled

The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter sent an "Urgent Product Corrective Action" letter dated June 29, 2010, with attached Customer Response form to the affected customers. The letter identified the affected product and issue. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers 916271, 917073, and 918433. (2) Review results in the context of the total clinical presentation of the patient, and rerun questionable results using another reagent. (3) Complete and return a response form within 10 days. (4) For replacement contact Beckman Coulter at (US) 1-800-526-3821, (Canada) 1-800-463-7828. Customer Technical Support can be contacted at 1-800-854- 3633.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Worldwide distribution : United States, including states of CA, CO, FL, GA. IA, IL, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and country of Canada.

Timeline

Recall initiated: 2010-06-29
Posted by FDA: 2010-09-02
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.