VITROS Chemistry LAC Slides Affected by Increased Calibration Failures
Certain VITROS Chemistry LAC Slides are failing to calibrate properly, delaying test results. Affected lots are from coating 0130 and above with expiration dates through January 2027.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported adverse events, hospitalizations, or illnesses. The issue is a manufacturing defect causing increased calibration failure rates (1% vs. 0.03–0.06% baseline), which delays test results rather than causing direct patient harm.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products LAC Slides (Catalog Number 8433880), a medical device used for clinical laboratory testing on VITROS XT 3400 and VITROS XT 7600 systems. The recall affects approximately 2,908 units distributed nationwide.
The affected slides are experiencing an increased occurrence of calibration failure affecting certain lot numbers with coating 0130 and above. The failure is characterized by Condition Code TH4-63J during calibration, which causes a delay in LAC test results. The failure rate for affected coatings was 1% in 2025, compared to 0.06% for other coatings in 2025 and 0.03% for all coatings in 2024.
The issue was identified through an increase in customer complaints compared to the historical baseline. Affected slides have expiration dates ranging from September 2026 to January 2027. The calibration failure has the potential to impact patient management decisions that depend on timely test results.
The recalled product
- Product
- Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- calibration-failure
- delayed-test-results
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 (15)
- Catalog number 8433880
- UDI# 110758750004911
- Coating 0130 and above
- this includes Lot numbers 3533-0130-2317
- 3533-0130-2717
- 3533-0130-2718
- 3533-0130-2719
- 3533-0130-4546
- 3533-0130-4605
- 3533-0131-4763
- 3533-0131-6114
- 3533-0131-6115
- 3533-0131-6116
- 3533-0131-6128
- Expiration date range 01-Sep-2026 to 01-Jan-2027
Distribution
Distributed nationwide across the United States.
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