VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- December 10, 2021
- Recall Number
- Z-0735-2022
- Quantity
- 4125 units
- Firm Location
- Rochester, NY
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.
Lot / Code Info
UDI 10758750006786 Lot 1039734
Root Cause
Nonconforming Material/Component
Action Taken
On December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.