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Beckman Coulter Inc. recalls Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothy
Recalled August 29, 2012 · FDA recall Z-2227-2012 · Beckman Coulter
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. · FDA Class III
Units
117,385 units total (33,918 units in US)
Sold at
Worldwide Distribution - USA (nationwide), Canada, and internationally.
Description
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.
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →