VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures to...
FDA Device Recall #Z-0845-2021 — Class II — December 15, 2020
Recall Summary
| Recall Number | Z-0845-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 15, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho Clinical Diagnostics Inc |
| Location | Raritan, NJ |
| Product Type | Devices |
| Quantity | US=9802; OUS: 1298 Total: 11,100 |
Product Description
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
Reason for Recall
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
Lot / Code Information
All Current, Future and Past Lots UDI: 10758750031771
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-0770-2021 | Class II | VITROS Chemistry Products CKMB Slides: (1)VI... | Dec 11, 2020 |
| Z-0471-2021 | Class III | VITROS Chemistry Products Performance Verifier ... | Oct 16, 2020 |
| Z-0451-2021 | Class II | VITROS¿ Immunodiagnostic Products Anti-SARS-CoV... | 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.