Home / Recalls / Nanosphere, Inc. / Z-2168-2014

Z-2168-2014 Class III Terminated

Recalled by Nanosphere, Inc. — Northbrook, IL

Recall Details

Product Type
Devices
Report Date
August 20, 2014
Initiation Date
October 16, 2013
Termination Date
May 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
280 sets of trays

Product Description

Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. 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 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. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

Reason for Recall

Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.

Distribution Pattern

US Distribution including the states of CA and WA

Code Information

Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E

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-2683-2014 Class II — The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed usi (October 10, 2013)
  • Z-2682-2014 Class II — The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, mul (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)