Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes...
FDA Device Recall #Z-2278-2015 — Class II — June 26, 2015
Recall Summary
| Recall Number | Z-2278-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 26, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hardy Diagnostics |
| Location | Santa Maria, CA |
| Product Type | Devices |
| Quantity | 100 each and 1,860 each (186 pk/10) |
Product Description
Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
Reason for Recall
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
Distribution Pattern
U.S. Nationwide Distribution and the country of: Canada
Lot / Code Information
Lot number: 15070 Cat no. R98 Lot number: 14193, 14232, 14251, 14272, and 14329 Cat no.: R72
Other Recalls from Hardy Diagnostics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2041-2025 | Class II | HardyCHROM CRE, selective and differential cult... | May 6, 2025 |
| Z-1835-2021 | Class II | Quickslide GramPro 1 Automated Gram Stanier is ... | Apr 16, 2021 |
| Z-0919-2021 | Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomyc... | Dec 21, 2020 |
| Z-0655-2021 | Class II | Viral Transport Medium, 3ml, Ref: R99, Containe... | Oct 23, 2020 |
| Z-0441-2021 | Class III | Strep B Carrot Broth One-Step, Ref. Z40, UDI: ... | Oct 6, 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.