FDA Enforcement
Class II
Terminated
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.
Recall: Z-1648-2014
·
Reported May 28, 2014
Enforcement
- Recall Number
- Z-1648-2014
- Event ID
- 67643
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 28, 2014
- Initiation Date
- February 20, 2014
- Classification Date
- May 21, 2014
- Termination Date
- April 19, 2017
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
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
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Code Info
Catalog Number: 139 3396, Lot Number: 1590
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.
Quantity
583 units Total (357 units domestically & 226 units internationally)