FDA-Device2012-08-29Class III
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.
Beckman Coulter Inc.
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.
Sold states
Worldwide Distribution - USA (nationwide), Canada, and internationally.
Affected count
117,385 units total (33,918 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2012Don't want to check this manually?
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