VITROS Chemistry LAC Slides Calibration Failure Causes Test Delays
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides due to increased calibration failures that delay test results on clinical laboratory analyzer systems. Approximately 2,320 units are affected nationwide.
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 is a Class II medical device recall involving a risk-of-harm product where a diagnostic equipment malfunction could delay critical patient test results. No injuries or illnesses have been reported, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products LAC Slides (Catalog Number 8150112) distributed nationwide in the United States. Approximately 2,320 units are affected. The slides are used with VITROS XT 3400 and VITROS XT 7600 chemistry analyzer systems for lactate testing in clinical laboratories.
The company identified an increased rate of calibration failures in affected lots. During 2025, lots with coating 0130 experienced an average failure rate of 1%, compared to 0.06% for other coatings in the same period and 0.03% for all coatings in 2024. These failures occur during calibration, marked as Condition Code TH4-63J, and prevent the analyzer from completing lactate test results.
When the analyzer experiences calibration failure, it cannot generate lactate test results, causing delays in test reporting. Lactate measurement is critical in emergency and intensive care settings for patient management. The failure was discovered through an increase in customer complaints compared to historical baseline rates.
Laboratory personnel should verify inventory using Catalog Number 8150112 and confirm whether affected units have coating lot numbers 0130 and above with expiration dates between October 1, 2026 and January 1, 2027. Specific lot numbers are provided in the official FDA recall notice. Contact Ortho-Clinical Diagnostics for corrective action or replacement supplies.
The recalled product
- Product
- VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- calibration-failure
- test-result-delay
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 (14)
- Catalog number 8150112
- UDI# 10758750004454
- Coating 0130 and above
- this includes Lot numbers 3533-0130-2947
- 3533-0130-2972
- 3533-0130-3001
- 3533-0130-3002
- 3533-0130-3048
- 3533-0130-3084
- 3533-0131-5887
- 3533-0131-5958
- 3533-0131-5962
- 3533-0131-6058
- Expiration date range 01-Oct-2026 to 01-Jan-2027
Distribution
Distributed nationwide across the United States.
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