VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Enforcement
- Recall Number
- Z-2335-2025
- Event ID
- 97210
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 27, 2025
- Initiation Date
- July 9, 2025
- Classification Date
- August 15, 2025
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
Description
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
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.
Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;
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.
174,215 units