Ortho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures
Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential quality control issue (calibration failure) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators, Catalog Number 139 3396, Lot Number 1590. The product is used for the quantitative measurement of total thyroxine (T4) in human serum and plasma to aid in the differential diagnosis of thyroid disease.
The recall was initiated because the calibrators may experience calibration failures or produce low Quality Control results. A total of 583 units were distributed, with 357 units distributed domestically in the United States and 226 units distributed internationally to Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy, and Spain.
Healthcare facilities and laboratories should stop using the affected calibrators and contact Ortho-Clinical Diagnostics for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- 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 differenti
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 139 3396
- Lot Number: 1590
Distribution
Distributed nationwide across the United States.
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