Recall Z-2355-2010 ยท JNL Immunochemical, Thyroglobulin Autoantibody
Beckman Coulter Inc.
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.
| Date | Sep 2, 2010 (initiated Jun 29, 2010) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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) 1-800-526-38 |
| Quantity | 1071 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) Beckman Coulter, Inc., Oct 5, 2006 |