Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridge...
FDA Device Recall #Z-2236-2014 — Class II — July 9, 2014
Recall Summary
| Recall Number | Z-2236-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 9, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nanosphere, Inc. |
| Location | Northbrook, IL |
| Product Type | Devices |
| Quantity | 1045 extraction trays (840 affected by recall) |
Product Description
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Reason for Recall
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
Distribution Pattern
Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Lot / Code Information
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
Other Recalls from Nanosphere, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2170-2014 | Class II | Verigene Gram-Negative Blood Culture Nucleic Ac... | Apr 17, 2014 |
| Z-2559-2014 | Class III | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Tes... | Mar 18, 2014 |
| Z-2168-2014 | Class III | Nanosphere Verigene Each CDF test consists ... | Oct 16, 2013 |
| Z-2685-2014 | Class II | The Verigene Enteric Pathogens Nucleic Acid Tes... | Oct 10, 2013 |
| Z-2684-2014 | Class II | The Verigene Respiratory Virus Plus Nucleic Aci... | Oct 10, 2013 |
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.