VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Published March 16, 2022 · Recall initiated: December 10, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- Domestic distribution nationwide. Foreign distribution to Canada.
- Lot
- UDI 10758750006786 Lot 1039734
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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