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Sources: EU EUDAMED, US FDA
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The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·April 22, 2020
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code LXG·March 9, 2020
MagNA Pure LC 1.0 (software version 3.0.11). Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LXG·February 22, 2007
Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc.·Product code LXG·May 11, 2016
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
APTIO 9000 REFRIGERATED STORAGE MODULE
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
FDA Recall
Terminated
·Biomerieux Inc·Product code LXG·August 28, 2012
AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LXG·May 7, 2009
MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code LXG·July 21, 2011
APTIO 15000 REFRIGERATED STORAGE MODULE
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
APTIO CENTRIFUGE MODULE
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
FDA Recall
Terminated
·Siemens Medical Solutions Diagnostics·Product code LXG·April 25, 2014
FP1000 Cell Preparation System Part Number 624922
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LXG·June 26, 2006
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma).
FDA Recall
Terminated
·Tecan US, Inc.·Product code LXG·July 25, 2016
APTIO RACK OUTPUT MODULE
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
APTIO INPUT/OUTPUT MODULE
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
STREAMLAB CORE UNIT / LYNX WITH IOM
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LXG·August 14, 2018
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
FDA Recall
Terminated
·Biomedical Polymers, Inc.·Product code LXG·September 18, 2019
Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V)), 6605628 (TN; 5 CLR, FC500 (120V)) , 6605629 (TN; 5 CLR, FC500 (220V)), 6605630 (TN; 5 CLR, FC500 (240V)) with CXP Software Versions 2.0 and 2.1
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LXG·May 22, 2006