FDA Enforcement
Class III
Terminated
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.
Recall: Z-2227-2012
·
Reported August 29, 2012
Enforcement
- Recall Number
- Z-2227-2012
- Event ID
- 62791
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2012
- Initiation Date
- October 11, 2011
- Classification Date
- August 20, 2012
- Termination Date
- March 14, 2013
- Address
- 250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States
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
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.
Code Info
All Lots
Distribution
Worldwide Distribution - USA (nationwide), Canada, and internationally.
Quantity
117,385 units total (33,918 units in US)