FDA Device recall Z-2227-2012
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in…
- FDA Device
- Class III
- terminated
- Published 2012-08-29
On 2012-08-29 the FDA classified a Class III recall of Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in… by Beckman Coulter, citing 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 sam….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2227-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-10-11 |
| Published | 2012-08-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2227-2012%22
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