VITROS TT4 Calibrator For the quantitative measurement of total… — Class II medical device recall Z-1648-2014
Terminated recall by Ortho-Clinical Diagnostics, reported 2014-05-28, distributed nationwide. Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
| Recall number | Z-1648-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2014-02-20 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2017-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, CO, DE, ES, GB, IN, IT, JP, MX, PA, SG, VE |
| Lot numbers | 1590 |
| Model numbers | 139, 3396 |
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 for recall
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1648-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.