Z-2682-2014Class II

The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic...

Name: Z-2682-2014 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic...
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 Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA)... 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-2682-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2014-09-23
Terminated: 2015-06-16
Recalling firm: Luminex Corporation
Product: The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.
Product code: OZN C. Difficile Toxin Gene Amplification Assay
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: 80 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: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2682-2014
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 OZN

K123197Class IIVerigene C. Difficile Nucleic Acid Test (Cdf)Nanosphere, Inc. / cleared 2012-12-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)