Enforcement Report - Week of August 29, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2227-2012 |
| Classification | Class III |
| Code Info | All Lots |
| Product Distributed Qty | 117,385 units total (33,918 units in US) |
| 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. |
Event Detail
| Event Id | 62791 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Beckman Coulter Inc. |
| City | Brea |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-10-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide), Canada, and internationally. |
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