Recall Z-0313-2017

Reason for recall

The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.

FDA-determined cause: Under Investigation by firm

Action taken

The firm, Ortho Clinical Diagnostics, distributed "Important Product Correction Notification" letters (Ref. CL2016-129) dated 6/22/2016 and Confirmation of Receipts to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only). Foreign affiliates were informed by email (on 22 June 2016) of the issue and instructed to notify their consignees of the issue and required actions. All customers who received the affected product were instructed to immediately discontinue using and discard the affected lots. Forward a copy of the notification if you have provided the affected lot(s) outside of your facility. Post a copy of the notification by each VITROS System that processes VITROS HBsAg Controls and Complete and return the Confirmation of Receipt-Response Required form via fax to: 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM no later 7/1/2016. (Note: If you DO NOT have an alternate lot, it is acceptable to continue using the affected lot(s) following these instructions: 1) Control results must be within acceptable limits on the day of reconstitution (Day 1). 2) Store open-reconstituted vials frozen for up to 4 weeks. The firm recommends that customers aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. 3) Upon receipt of your replacement order, discard all remaining inventory. Customers with questions please call the Ortho Technical Solutions Center at 1-800-421-3311.