Home / Recalls / Nanosphere, Inc. / Z-2682-2014

Z-2682-2014 Class II Terminated

Recalled by Nanosphere, Inc. — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
October 1, 2014
Initiation Date
October 10, 2013
Termination Date
June 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80 units

Product Description

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.

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.

Code Information

Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14

Other recalls by Nanosphere, Inc.

  • Z-2236-2014 Class II — Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC- (July 9, 2014)
  • Z-2170-2014 Class II — Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using (April 17, 2014)
  • Z-2559-2014 Class III — Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of (March 18, 2014)
  • Z-2168-2014 Class III — Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Te (October 16, 2013)
  • Z-2683-2014 Class II — The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed usi (October 10, 2013)
  • Z-2684-2014 Class II — The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene Syst (October 10, 2013)
  • Z-2681-2014 Class II — The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed us (October 10, 2013)
  • Z-2685-2014 Class II — The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitat (October 10, 2013)
  • Z-2736-2014 Class II — Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartri (June 17, 2013)
  • Z-2735-2014 Class II — Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartri (June 17, 2013)