Recall Z-2227-2012 ยท CDP Radioimmunoassay, Total Triiodothyronine
Beckman Coulter Inc.
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
| Date | Aug 20, 2012 (initiated Oct 11, 2011) |
| Status | Terminated |
| Reason | A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0. |
| Root cause | Device Design |
| Action | Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The PCA letter informed the customers of the problem identified and the actions to be taken. Customers were informed to stop SDA usage as an alternative dilutent and that the S0 dilutent is to be used for manual dilution of the patient sample for Total T3. They will also be informed to no longer use the On Board Dilution (OBD) option for Total T3. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding this notification |
| Quantity | 117,385 units total (33,918 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide), Canada, and internationally. |
| FDA record | Open on fda.gov |