105 results
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27ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·August 2, 2017
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
FDA Recall
Terminated
·PerkinElmer Health Sciences, Inc.·Product code PJC·May 31, 2017
PerkinElmer 226 Sample Collection Device
FDA Recall
Terminated
·PerkinElmer Health Sciences, Inc.·Product code PJC·December 19, 2017
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
FDA Recall
Terminated
·Perkin Elmer Health Sciences, Inc.·Product code JKA·September 5, 2013
PerkinElmer 226 Sample Collection Device
FDA Enforcement
Class III
·Terminated·PerkinElmer Health Sciences, Inc.·June 10, 2020
JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
FDA Enforcement
Class III
·Terminated·Perkinelmer Life Sciences, Inc.·March 7, 2018
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
FDA Enforcement
Class II
·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 5, 2017
PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872
FDA Enforcement
Class II
·Terminated·PerkinElmer Health Sciences Canada, Inc.·December 5, 2018
Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·June 3, 2015
Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·June 3, 2015
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·June 3, 2015
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·June 3, 2015
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015
Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
FDA Recall
Terminated
·Perkinelmer·Product code JJJ·December 8, 2015