Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
The recalled product is VITROS Chemistry Products LAC Slides, Catalog Number 8150112. Each sales unit contains 5 cartridges of 18 slides, totaling 90 tests. The distribution of this product occurred nationwide in the United States.
Calibration failures in the LAC Slides can delay lactate test results. Customers reported an average failure rate of 1% for coating 0130 in 2025, significantly higher than the 0.06% failure rate for other coatings in the same year.
The recall follows an increase in customer complaints compared to historical data. There are no specific reported injuries or deaths related to this issue.
Stop using the VITROS Chemistry Products LAC Slides immediately. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for further instructions and follow the provided recall instructions.
For more details, patients and healthcare providers can visit the recall page at the FDA website or contact Ortho-Clinical Diagnostics.
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