Recall Z-1949-2011 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Beckman Coulter Inc.
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper
| Date | Apr 12, 2011 (initiated Mar 10, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm |
| Root cause | Other |
| Action | Beckman Coulter sent an Urgent Product Correction letter dated March 20, 2011, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignees were issued the following instructions: (1) If you suspect pregnant patient results were evaluated at your laboratory using only Total T4 to report thyroid status, consider reviewing Total T4 results reported in the last 9 months. Consult with your Laboratory Medical Director and requesting physician to resolve any concerns you may have regarding previously reported patient results |
| Quantity | 151,740 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel |
| FDA record | Open on fda.gov |