VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides,...
FDA Device Recall #Z-1226-2014 — Class II — January 9, 2014
Recall Summary
| Recall Number | Z-1226-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 9, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 64 units worldwide |
Product Description
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
Reason for Recall
An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Lot / Code Information
Lot 9052-0045-6358, expiry date 01 Aug 2015
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.