Product Wiki · Recalls · U.S. FDA — Device Enforcement

Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used… — recall Z-2227-2012

U.S. FDA — Device Enforcement · United States · 2011-10-11 · Class III

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2227-2012
Date of alert
2011-10-11
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA (nationwide), Canada, and internationally.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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