Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680...

FDA Device Recall #Z-0755-2013 — Class II — December 13, 2012

Recall Summary

Recall Number Z-0755-2013
Classification Class II — Moderate risk
Date Initiated December 13, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho-Clinical Diagnostics
Location Rochester, NY
Product Type Devices
Quantity Domestic: 15,891; Foreign: 5237

Product Description

Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems.

Reason for Recall

Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS¿ System instead of the intended VITROS¿ Vapor Adsorption Cartridge which may bias results.

Distribution Pattern

Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.

Lot / Code Information

CAT No. 680 0100; the cartridges do not have lot numbers.

Other Recalls from Ortho-Clinical Diagnostics

Recall # Classification Product Date
Z-1372-2024 Class II VITROS Performance Verifier I Feb 27, 2024
Z-1373-2024 Class II VITROS Performance Verifier II Feb 27, 2024
Z-2358-2023 Class II VITROS Immunodiagnostic Products Troponin I ES ... Jun 5, 2023
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

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.