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.
Reported: August 29, 2012 Initiated: October 11, 2011 #Z-2227-2012
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 117,385 units total (33,918 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide), Canada, and internationally.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 117,385 units total (33,918 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Low. Recall number: Z-2227-2012.
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