Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-res...
FDA Device Recall #Z-2170-2014 — Class II — April 17, 2014
Recall Summary
| Recall Number | Z-2170-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nanosphere, Inc. |
| Location | Northbrook, IL |
| Product Type | Devices |
| Quantity | 580 test cartridges |
Product Description
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. 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. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization.
Reason for Recall
Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca
Distribution Pattern
US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI
Lot / Code Information
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14
Other Recalls from Nanosphere, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2236-2014 | Class II | Verigene BC-GN Test Kit (Catalog number 20-005-... | Jul 9, 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.