Class 2 Device Recall VITROS Chemistry Products Ca Slide

• Date Initiated by Firm: July 09, 2025
• Date Posted: August 15, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2335-2025
• Recall Event ID: 97210
• 510(K)Number: K072440
• Product Classification: Azo dye, calcium - Product Code CJY
• Product: VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261
• Code Information: Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Laurie O'Riordan; 1-954-6239546
• Manufacturer Reason for Recall: Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.
• FDA Determined Cause: Under Investigation by firm
• Action: On July 9, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTIONS " Upon receipt, load ADD DRV 6338 on your VITROS XT 3400 and/or VITROS XT 7600 System(s). " Complete the enclosed Confirmation of Receipt form no later than July 17, 2025. " Save this notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " 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. Resolution The issue resolves upon loading ADD DRV 6338 however, QuidelOrtho s investigation to determine root cause is still in progress. We apologize for the inconvenience this issue may have caused your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088. *****Update 8/4/2025***** On July 29, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers of additional products identified for this event. REQUIRED ACTIONS " Upon receipt, load ADD DRV 6339 (or above) on your VITROS XT 3400 and/or VITROS XT 7600 System(s). " Complete the enclosed Confirmation of Receipt form no later than August 6, 2025. " Save this notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has ex
• Quantity in Commerce: 174,215 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, 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 = CJY