Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains…

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.

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

On 29 July 2025, QuidelOrtho mailed a hardcopy customer letter (Ref. CL2025-201) via FedEx overnight courier and/ or electronically sent the customer letter using ORTHO PLUS e-Communications to customers. Consignees were instructed to load ADD DRV 6339 (or above) on your VITROS XT 3400 and/or VITROS XT 7600 System(s), complete and return the provided Confirmation of Receipt, save the notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved, and forward the information if affected units were further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-2560-2025
• FDA 510(k) clearance · K955286The device's official FDA premarket clearance record
• FDA device classification · KHPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1450The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ortho-Clinical Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.