FDA-Device2025-09-24Class II

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

Ortho-Clinical Diagnostics, Inc.

Hazard

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.

Sold states

US Nationwide distribution.

Affected count

2,320 units

Manufactured in

100 Indigo Creek Dr, N/A, Rochester, NY, United States

Products

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2560-2025

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