Z-2684-2014Class II

The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic...

Name: Z-2684-2014 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic...
Creator: Nanosphere, Inc.
Published: 2013-10-10
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2013-10-10 / Terminated / root cause: manufacturing process

FDA source

Nanosphere, Inc. began a recall of The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously... on 2013-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2684-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2014-09-23
Terminated: 2015-06-16
Recalling firm: Luminex Corporation
Product: The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative. For questions regarding this recall call 1-888-837-4436, ext 3.
Quantity in commerce: 780 units
Distribution: 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.
Product codes and lots: Product Number: 20-009-020; Lot Number and Expiration Date: Lot: 091113020B, Expiration Date: 03/10/14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2684-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2681-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23
Z-2682-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23
Z-2683-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23
Z-2684-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23
Z-2685-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

Product code OCC

K103209Class IIVerigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. / cleared 2011-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)