Class 2 Device Recall VITROS Lipase Slides

• Date Initiated by Firm: September 12, 2023
• Date Posted: November 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0236-2024
• Recall Event ID: 93238
• Product Classification: Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
• Product: VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
• Code Information: Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, INc.; 513 Technology Blvd; Rochester NY 14626-3601
• For Additional Information Contact: Joe Falvo; 585-453-3452
• Manufacturer Reason for Recall: Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT PRODUCT CORRECTION NOTIFICATION letter was sent to customers on 9/12/23. REQUIRED ACTIONS " Discontinue using, render unusable, and discard any remaining inventory of VITROS Lipase Slides, Lots 5905-3348-1557 and/or 5905-3348-2899, from your laboratory. " If you have one, use a lot other than 5905-3348-1557 and/or 5905-3348-2899 of VITROS Lipase slides for testing. " Complete and return the enclosed Confirmation of Receipt form no later than September 20, 2023. " Upon completion and return of the enclosed Confirmation of Receipt form, QuidelOrtho will send a replacement lot or credit your account. " Ensure your laboratory follows the calibration instructions provided in the VITROS Lipase Slides Instructions For Use. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System until your laboratory receives a lot of VITROS Lipase Slides unaffected by this issue. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 342 units
• Distribution: US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea
• 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.