FDADecember 10, 2021device

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750006786

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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