Device product
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.
Z-2227-2012
Product summary
- Event
- Event 62791
- Status
- Terminated
- Classification
- Class III
- Quantity
- 117,385 units total (33,918 units in US)
- Official record key
device-enforcement:Z-2227-2012
Official wording
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.
Code information: All Lots
Distribution pattern: Worldwide Distribution - USA (nationwide), Canada, and internationally.
Derived failure modes
-
Unknown
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.