VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 1...

FDA Device Recall #Z-2183-2014 — Class II — July 16, 2014

Recall Summary

Recall Number Z-2183-2014
Classification Class II — Moderate risk
Date Initiated July 16, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ORTHO-CLINICAL DIAGNOSTICS
Location Bridgend, N/A
Product Type Devices
Quantity 475

Product Description

VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.

Reason for Recall

Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to France and Japan

Lot / Code Information

Lot 1320, Product code: 6800035 and 6800040

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.