VITROS Immunodiagnostic Products Troponin I ES Calibrators

FDA Device Recall #Z-2358-2023 — Class II — June 5, 2023

Recall Summary

Recall Number Z-2358-2023
Classification Class II — Moderate risk
Date Initiated June 5, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ORTHO-CLINICAL DIAGNOSTICS
Location Bridgend, N/A
Product Type Devices
Quantity 4,013 units

Product Description

VITROS Immunodiagnostic Products Troponin I ES Calibrators

Reason for Recall

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Lot / Code Information

Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.

Other Recalls from ORTHO-CLINICAL DIAGNOSTICS

Recall # Classification Product Date
Z-1373-2024 Class II VITROS Performance Verifier II Feb 27, 2024
Z-1372-2024 Class II VITROS Performance Verifier I Feb 27, 2024
Z-2357-2023 Class II VITROS Immunodiagnostic Products Troponin I ES ... Jun 5, 2023
Z-2129-2023 Class II VITROS Chemistry Products Calibrator Kit 20-in ... May 8, 2023
Z-2873-2020 Class II VITROS Chemistry Products TBIL Slides- 5 PACK/3... Jul 13, 2020

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.