Recall Z-0417-2007 ยท DDC Thyroglobulin, Antigen, Antiserum, Control
Beckman Coulter Inc
Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
| Date | Feb 7, 2007 (initiated Oct 26, 2006) |
| Status | Terminated |
| Reason | Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days. |
| Quantity | 474 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 Beckman Coulter, Inc., Sep 7, 2001 |