Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the perf...
FDA Device Recall #Z-0191-2013 — Class III — March 24, 2011
Recall Summary
| Recall Number | Z-0191-2013 |
| Classification | Class III — Low risk |
| Date Initiated | March 24, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Clinical Diagnostic Solutions |
| Location | Plantation, FL |
| Product Type | Devices |
| Quantity | 197 vials |
Product Description
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Reason for Recall
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Distribution Pattern
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
Lot / Code Information
Product Part 502-012, Lot #1102-574
Other Recalls from Clinical Diagnostic Solutions
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1436-2014 | Class II | Boule Con-Diff Tri-Level Multi-Parameter Assay... | Feb 24, 2013 |
| Z-0189-2013 | Class III | Boule Con-Diff Hematology Control For in vit... | Mar 24, 2011 |
| Z-0190-2013 | Class III | Boule Con-Diff Hematology Control For in vit... | Mar 24, 2011 |
| Z-0193-2013 | Class III | Boule Con Diff US Tri Pack, 6 Vials. For in ... | Aug 4, 2010 |
| Z-0194-2013 | Class III | Boule Con-Diff Hematology Control 9 vials. F... | Aug 4, 2010 |
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.