Class 2 Device Recall VITROS Chemistry Products VALP Reagent Pack

• Date Initiated by Firm: December 11, 2018
• Create Date: February 19, 2019
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-0848-2019
• Recall Event ID: 81806
• 510(K)Number: K042476
• Product Classification: Enzyme immunoassay, valproic acid - Product Code LEG
• Product: VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
• Code Information: Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748
• FEI Number: 1000305841
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 1000 Lee Road; Rochester NY 14606
• For Additional Information Contact: SAME; 585-724-2210
• Manufacturer Reason for Recall: Negative bias results when using VITROS VALP Reagent, GEN 25.
• FDA Determined Cause: Process control
• Action: 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..
• Quantity in Commerce: 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
• Distribution: Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LEG