Recall Z-1648-2014— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-02-20, terminated 2017-04-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-20
- Terminated
- 2017-04-19
- Firm location
- Rochester, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.