Recall Z-0848-2019

Reason for recall

Negative bias results when using VITROS VALP Reagent, GEN 25.

FDA-determined cause: Process control

Action taken

The firm, Ortho Clinical Diagnostics, issued on 11 December 2018, a "URGENT PRODUCT CORRECTION NOTIFICATION" customer letter (Ref. CL2018-267) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who were shipped VITROS Chemistry Products VALP GEN 25. Foreign affiliates were informed by email on 11 December 2018 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. The customers were notified of the issue and instructed to cease use of VALP GEN 25. If you have any GEN 25 (Lot 25-6393) remaining in your inventory, Ortho will provide replacement or credit your account. " Discontinue using Gen 25 (Lot 25-6393), discard any remaining inventory, and switch to GEN 26 or above. " If you do NOT have GEN 26 or above at this time, consider the following alternate options: o Use an alternate valproic acid method until your replacement order arrives. o Consult with your medical director to determine if the bias observed when using GEN 25 is acceptable for continued use, and if so, continue to use until your replacement arrive. In accordance with regulatory requirements, complete and return the Confirmation of Receipt - Response form no later than December 19, 2018 via Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. " Post this notification by your VITROS System or with your user documentation. " Forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311..