Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715
Recalled Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Hazard / Issue
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Issued by
FDA
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