FDA recall Z-0735-2022

Ortho-Clinical Diagnostics, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2021-12-10
Report date
2022-03-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2022