Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative dete...
FDA Recall #Z-2227-2012 — Class III — October 11, 2011
Product Description
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.
Reason for Recall
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.
Recalling Firm
Beckman Coulter Inc. — Brea, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
117,385 units total (33,918 units in US)
Distribution
Worldwide Distribution - USA (nationwide), Canada, and internationally.
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated