Ortho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.
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 the hazard involves potential diagnostic inaccuracy (negative bias) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Total T4 Reagent Packs. The recall involves specific lot numbers of the reagent packs used for the quantitative measurement of total thyroxine (T4) in human serum and plasma.
The recall was initiated because sample results generated from these reagent packs may show a negative bias prior to the open pack storage limit of 8 weeks or less, as stated in the Instructions for Use. This potential bias could affect the accuracy of thyroid disease diagnosis.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico), Canada, and Bermuda. Users of the VITROS ECi/ECiQ, VITROS 3600, and VITROS 5600 systems should stop using the affected reagent packs and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (E
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Hazard
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 (18)
- Lot Numbers:1836
- 1840
- 1845
- 1850
- 1860
- 1870
- 1880
- 1890
- 1900
- 1910
- 1920
- 1930
- 1940
- 1950
- 1968
- 1978
- 1988
- 1998
Distribution
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