VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative meas...
FDA Device Recall #Z-1152-2013 — Class II — March 14, 2013
Recall Summary
| Recall Number | Z-1152-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | Domestic: 11,164 units, Foreign: 594 units |
Product Description
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Reason for Recall
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Lot / Code Information
All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
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.