Recall Z-0735-2022 ยท JRC Micro Pipette
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
| Date | Dec 10, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 4125 units |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.