Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total o

FDA device recall Z-2559-2025 · posted 2025-09-12 · Open, Classified

Recall details

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Reason for recall: 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.
Action taken: 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.
Root cause: Device Design
Status: Open, Classified
Product code: KHP
Quantity affected: 2,908 units
Distribution: US Nationwide distribution.
Date initiated: 2025-07-29
Date posted: 2025-09-12
Location: Rochester, NY

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Related 510(k) clearances

Record	Firm	Date
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU) (K955286)	Johnson & Johnson Clinical Diagnostics, Inc.	1996-05-17