VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemist...

FDA Device Recall #Z-0471-2021 — Class III — October 16, 2020

Recall Summary

Recall Number Z-0471-2021
Classification Class III — Low risk
Date Initiated October 16, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho Clinical Diagnostics Inc
Location Raritan, NJ
Product Type Devices
Quantity 10788 total: US 4680; OUS 6108

Product Description

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Reason for Recall

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Lot / Code Information

Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Other Recalls from Ortho Clinical Diagnostics Inc

Recall # Classification Product Date
Z-0120-2022 Class II VITROS Immunodiagnostic Products Anti-SARS-CoV-... Sep 10, 2021
Z-0844-2021 Class II VITROS Chemistry Products TP Slides- IVD measur... Dec 15, 2020
Z-0845-2021 Class II VITROS XT Chemistry Products ALB-TP Slides (ALB... Dec 15, 2020
Z-0770-2021 Class II VITROS Chemistry Products CKMB Slides: (1)VI... Dec 11, 2020
Z-0450-2021 Class II VITROS Immunodiagnostic Products-SARS-CoV-2 IgG... Sep 30, 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.