Class 2 Device Recall VITROS Chemistry Products VANC Reagent

• Date Initiated by Firm: February 21, 2017
• Create Date: April 27, 2017
• Recall Status: Terminated on June 19, 2019
• Recall Number: Z-1887-2017
• Recall Event ID: 76551
• 510(K)Number: K043386
• Product Classification: Radioimmunoassay, vancomycin - Product Code LEH
• Product: VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
• Code Information: Lot numbers: 31-5407 (exp. date 2017-05-23), 31-5474 (exp. date 2017-07-04), 31-5506 (exp. date 2017-07-04)
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Ms. Jennifer Paine; 908-218-8776
• Manufacturer Reason for Recall: Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
• FDA Determined Cause: Under Investigation by firm
• Action: Ortho Clinical Diagnostics sent an IMPORTANT PRODUCT CORRECTION NOTIFICATION letter dated February 21, 2017, was 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 received the affected VITROS Chemistry Products VANC Reagent lots to inform them of the potential for biased results and to request that they immediately discontinue use of this product. Foreign affiliates were informed by e-mail on February 21, 2017, of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. The communication instructed customer to immediately discontinue use of the affected product. In order to minimize the disruption to the laboratory, the communication also provided the instructions for testing using the affected VANC lots until replacement product was received. If you have any further questions, please contact our OrthoCare Technical Solutions Ctr. at 1(800) 421-3311. For further questions regarding this recall, please call (908) 218-8776.
• Quantity in Commerce: US: 2740; OUS: 616
• Distribution: Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.
• 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 = LEH