Class 2 Device Recall VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

• Date Initiated by Firm: July 03, 2024
• Date Posted: August 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2580-2024
• Recall Event ID: 95020
• 510(K)Number: K001266 K984166
• Product Classification: Acid, folic, radioimmunoassay - Product Code CGN
• Product: VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
• Code Information: Model No 1513266; UDI/GTIN# 110758750009237; Lots within expiry: 3380, 3390, 3400, 3410, 3422, 3430, 3440, 3450, 3461, 3471, 3480.
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Joe Falvo; 585-4533452
• Manufacturer Reason for Recall: It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
• FDA Determined Cause: Software Design Change
• Action: On July 15, 2024, IMPORTANT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTION 1. Send the enclosed Customer Letter and Confirmation of Receipt form to all customers who were shipped VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 from your facility within the past 12 months. 2. Complete the enclosed Confirmation of Receipt form no later than July 23, 2024. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 18,467 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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