The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simu...
FDA Device Recall #Z-2685-2014 — Class II — October 10, 2013
Recall Summary
| Recall Number | Z-2685-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 10, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nanosphere, Inc. |
| Location | Northbrook, IL |
| Product Type | Devices |
| Quantity | 220 units |
Product Description
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
Reason for Recall
Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
Distribution Pattern
Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
Lot / Code Information
Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14
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-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-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.