VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridg...

FDA Device Recall #Z-2560-2025 — Class II — July 29, 2025

Recall Summary

Recall Number Z-2560-2025
Classification Class II — Moderate risk
Date Initiated July 29, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho-Clinical Diagnostics, Inc.
Location Rochester, NY
Product Type Devices
Quantity 2,320 units

Product Description

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

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.

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

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

Other Recalls from Ortho-Clinical Diagnostics, Inc.

Recall # Classification Product Date
Z-2559-2025 Class II Chemistry Products LAC Slides. Catalog Number: ... Jul 29, 2025
Z-2335-2025 Class II VITROS Chemistry Products Ca Slides; Catalog N... Jul 9, 2025
Z-2073-2025 Class II VITROS Chemistry Products OP Reagent Gen 15. Mo... Jun 12, 2025
Z-2121-2025 Class II Brand Name: VITROS Chemistry Products Product ... Jun 10, 2025
Z-2120-2025 Class II Brand Name: VITROS Chemistry Products Product ... Jun 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.