Ortho-Clinical Diagnostics, Inc. Recall 89362
Description: VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Ortho-Clinical Diagnostics, Inc. Recall 89362 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0735-2022 |
| Event ID | 89362 |
| Event Description | VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box. |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada. |
| Quantity | 4125 units |
| Recall 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. |
| Device Classification | 20220316 |
| Device Code Info | UDI 10758750006786 Lot 1039734 |
| Center Classification Date | 20220308 |
| Recall Initiation Date | 20211210 |
| Recalling Firm | Ortho-Clinical Diagnostics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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