246 results
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27ms
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Sources: EU EUDAMED, US FDA
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BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 5, 2014
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 5, 2014
BD Viper LT software, version 3.00H
FDA Enforcement
Class II
·Terminated·Bd Diagnostic·April 26, 2017
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 12, 2012
BD Viper LT software, version 3.00H
FDA Recall
Terminated
·Bd Diagnostic·Product code OOI·December 14, 2015
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 13, 2019
BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.
FDA Recall
Terminated
·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·November 11, 2008
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 20, 2007
BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JTN·February 19, 2007
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code PIC·January 14, 2019
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MDB·December 9, 2013
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·September 26, 2012
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MDB·December 9, 2013
BD Focal Point"100V, Catalog number: 490650 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 15 FOV under 5%, Catalog number: 490137. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"100V (Refurbished), Catalog number: 490651 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011
BD Focal Point"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
FDA Recall
Terminated
·Tripath Imaging, Inc.·Product code MKQ·October 6, 2011