75 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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.
FDA Recall
Terminated
·Nanosphere, Inc.·Product code OZN·October 10, 2013
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.
FDA Recall
Terminated
·Nanosphere, Inc.·Product code OZN·October 16, 2013
American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
FDA Recall
Terminated
·American Optisurgical Inc·Product code HQC·March 24, 2009
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code NBC·November 11, 2015
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
Dimension Assays: Triglycerides (TGL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assay: Lactate
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Assays: Uric Acid (URCA)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Triglycerides (TRIG)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Assays: ENZYMATIC CREATININE
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assay: LDL Cholesterol, Direct
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Uric Acid (URCA)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Vista Assays: Enzymatic Creatine (ECRE)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 17, 2020
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
Dimension Assays: Direct HDL Cholesterol (AHDL)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016