FDA Device recall Z-1648-2014
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS…
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS… by Ortho Clinical Diagnostics, citing total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1648-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-20 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Reason
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Identifiers
| code_info | Catalog Number: 139 3396, Lot Number: 1590 |
|---|
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-1648-2014%22
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