Recall Z-1818-2011 ยท JNL Immunochemical, Thyroglobulin Autoantibody
Beckman Coulter Inc.
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.
| Date | Mar 24, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | 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 | Other |
| 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 t |
| Quantity | 3658 units (1800 in US) |
| Distribution | 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, Georg |
| 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 |