Medical device chemistry slides recalled for increased calibration failures
Ortho-Clinical Diagnostics is recalling VITROS Chemistry calcium test slides that experience frequent calibration failures, potentially delaying diagnosis of serious calcium-related emergencies. A 19-fold increase in failure rates was documented in 2025 compared to 2024 baseline.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall affects a diagnostic device that produces calibration failures, potentially delaying diagnosis and treatment of serious calcium-related medical emergencies. No illnesses or injuries have been reported; the hazard is based on the theoretical risk of delayed diagnosis. This meets the High severity criterion: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Ca Slides (Catalog Number 145 0261), affecting approximately 174,215 units distributed worldwide. These diagnostic slides are used with VITROS XT 3400 and VITROS XT 7600 clinical chemistry analyzers to measure calcium levels in patient blood samples.
The affected slides—Generation 67 and above—are experiencing increased calibration failures. During the calibration process, the analyzer's imaging system detects imperfections in the slide images and generates an error code (TH4-63J) when a threshold is exceeded. The failure rate increased 19-fold from 0.0043% in 2024 to 0.082% in 2025, with all failures occurring at the lowest concentration calibration level.
When calibration fails, calcium test results are delayed or cannot be obtained. This delays diagnosis and treatment of serious calcium-related emergencies, such as hypercalcemic crisis and parathyroid disorders, which require urgent medical intervention.
Healthcare facilities using these analyzers should contact Ortho-Clinical Diagnostics for replacement slides or technical guidance. Users who encounter TH4-63J error codes during calcium calibration should consult the company's recall notification to determine if their slides are affected and to arrange for replacement units.
The recalled product
- Product
- VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- calibration-failure
- delayed-diagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: 145 0261
- UDI-DI: 10758750009114
- Affected GENs: 67 and above
Distribution
Distributed nationwide across the United States.
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