Class 2 Device Recall VITROS High Sample Diluent A (HSDA)

• Date Initiated by Firm: November 22, 2021
• Create Date: January 18, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0503-2022
• Recall Event ID: 89183
• Product Classification: General purpose reagent - Product Code PPM
• Product: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
• Code Information: Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898)
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Mr. Joe Falvo; 585-453-3000
• Manufacturer Reason for Recall: Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
• FDA Determined Cause: Under Investigation by firm
• Action: Ortho clinical Diagnostics issued an Important product correction notification on November 22, 2021. Actions to be taken by the Distributors: 1. Please provide the communication (Ref. CL2021-287) to customers who were shipped VITROS HSDA Lot 2190 from your facility. 2. Do not continue to distribute VITROS HSDA Lot 2190. 3. Complete the Confirmation of Receipt form no later than November 30, 2021. 4. Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311. Action to be taken by the customers: 1. Discontinue using VITROS HSDA Lot 2190 if your laboratory utilizes VITROS TSH Reagent Pack. 2.Complete the Confirmation of Receipt form no later than November 30, 2021, even if no replacement product is required. If replacement is required, indicate the quantity of VITROS HSDA Lot 2190 to be replaced. 3. Please forward this notification if the product was distributed outside of your facility. Contact Information If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311
• Quantity in Commerce: 1416 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.