FDAFDA · Food and drugs·Recall number Z-2227-2012
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.
Published August 29, 2012 · Recall initiated: October 11, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide Distribution - USA (nationwide), Canada, and internationally.
- Lot
- All Lots
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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