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.
Reported: May 28, 2014 Initiated: February 20, 2014 #Z-1648-2014
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 583 units Total (357 units domestically & 226 units internationally)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortho-Clinical Diagnostics. Units affected: 583 units Total (357 units domestically & 226 units internationally).
Why was this product recalled? ▼
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 28, 2014. Severity: Moderate. Recall number: Z-1648-2014.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11