VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
FDA Device Recall #Z-0307-2014 — Class II — June 12, 2013
Recall Summary
| Recall Number | Z-0307-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 12,484 units (9,040 units domestically & 3,444 units internationally) |
Product Description
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Reason for Recall
Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY including Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, Germany, France, Italy, and Spain.
Lot / Code Information
Multiple lots affected, with expiry dates through 22-Mar-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.