FDA-Device2022-03-16Class II
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Ortho-Clinical Diagnostics, Inc.
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.
Sold states
Domestic distribution nationwide. Foreign distribution to Canada.
Affected count
4125 units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0735-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief