Recall Z-2335-2025 ยท CJY Azo Dye, Calcium
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
| Date | Aug 15, 2025 (initiated Jul 9, 2025) |
| Status | Open, Classified |
| Reason | 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, w |
| Root 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 i |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) Ortho-Clinical Diagnostics, Inc., Sep 20, 2007 |