Ortho-Clinical Diagnostics, Inc. — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 9, 2025
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.
What's affected?
- Product
- VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
- Lot code
- Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;
Additional details
Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 174,215 units.
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