Class 2 Device Recall Ventana antiCD10 (SP67) Rabbit Monoclonal Primary Antibody

• Date Initiated by Firm: June 27, 2024
• Date Posted: August 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2644-2024
• Recall Event ID: 94985
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
• Code Information: UDI: 04015630972579/J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, and M00669
• FEI Number: 1000125183
• Recalling Firm/ Manufacturer: Ventana Medical Systems, Inc.; 1910 E Innovation Park Dr; Oro Valley AZ 85755-1962
• For Additional Information Contact: Roche Support Network Customer Support; 800-227-2155 Ext. 1
• Manufacturer Reason for Recall: Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On July 5, 2024, Ventana Medical Systems, Inc. a subsidiary of Roche Diagnostics issued a "Urgent Medical Device Correction" via UPS to affected consignees. Ventana asked consignees to take the following actions: 1. Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. 2. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. 3. Review all positive results generated with the affected lots. Follow your standard laboratory operating procedures to investigate any suspected false positive results generated with the affected lots. 4. If you performed your initial validation using an affected lot, you should revalidate. 5. Refer to the Product Replacement or Credit section on page three of this UMDC. To receive replacement product OR credit for the unexpired product currently in your inventory, use the following link to access the form: https://go.roche.com/TP-02194. 6. Complete all sections of the enclosed Recall Response form (TP-02195); fax or email it according to the instructions on the form even if you are not requesting replacement product or credit. " Share this notification with all device users within your facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred. " File this Urgent Medical Device Correction (UMDC) for future reference.
• Quantity in Commerce: 22,839 kits
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Albania, Argentina, Armenia, Australia, Azerbaijan, Bahrain, Belarus, Brazil, Cameroon, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Georgia, Ghana, Guatemala, Honduras, Hong Kong, India, Iran, Iraq, Israel, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mali, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nicaragua, Nigeria, North Macedonia, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Tanzania, Thailand, T¿rkiye, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
• 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.