VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VersaTips (Catalog No. 6801715) due to shape deformities in one lot that may reduce the volume of sample or reagent dispensed by up to 16 percent. If the resulting measurement errors go undetected, patients could receive reduced drug dosages or receive false positive or negative results for bloodborne infectious disease tests, particularly when results are close to the cut-off value.
The affected lot (Lot 1039734, UDI 10758750006786) consists of 4,125 units and was distributed nationwide in the United States as well as to Canada. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Domestic distribution nationwide. Foreign distribution to Canada. Quantity: 4125 units Lot/code info: UDI 10758750006786 Lot 1039734
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.