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Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

Company510(k)sRecalls
Beckman Coulter, Inc.1146
Ortho-Clinical Diagnostics, Inc.1130
Siemens Healthcare Diagnostics288
Abbott Laboratories1357
Roche Diagnostics Corp.042
Roche Diagnostics Operations, Inc.028
Eastman Kodak Company180
Boehringer Mannheim Corp.160
Abbott Gmbh & Co. KG014
Beckman Instruments, Inc.90
DateFirm and productCodeLinked 510(k)
Jan 7, 2021Ortho-Clinical Diagnostics, Inc.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest,
Terminated		 JJENone listed
Dec 8, 2020Roche Diagnostics Operations, Inc.
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Open, Classified		 JJEK191899
Dec 8, 2020Roche Diagnostics Operations, Inc.
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use
Open, Classified		 JJEK100853
Dec 2, 2020Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis o
Terminated		 JJEK151792
Dec 2, 2020Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis o
Terminated		 JJEK151792
Nov 23, 2020Roche Diagnostics Operations, Inc.
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Terminated		 JJEK191899
Jul 20, 2020Ortho Clinical Diagnostics
VITROS XT7600 Integrated System, Product code 6844461
Terminated		 JJEK182063
Jul 20, 2020Ortho Clinical Diagnostics
VITROS XT3400 Chemistry System, Product code 6844458
Terminated		 JJEK182063
Jun 19, 2020Abbott Gmbh & Co. KG
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Terminated		 JJENone listed
Jun 19, 2020Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Open, Classified		 JJEK151792
Jun 19, 2020Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Open, Classified		 JJEK151792
Jun 17, 2020Beckman Coulter Biomedical GmbH
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample pro
Terminated		 JJEK190298
May 20, 2020Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Terminated		 JJEK083173
May 20, 2020Ortho Clinical Diagnostics
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Terminated		 JJEK083173
May 20, 2020Ortho Clinical Diagnostics
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Terminated		 JJEK083173
May 20, 2020Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Terminated		 JJEK083173
May 20, 2020Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Terminated		 JJEK083173
May 15, 2020Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Terminated		 JJEK970227
May 15, 2020Siemens Healthcare Diagnostics Inc.
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
Terminated		 JJEK970227
May 12, 2020Abbott Gmbh & Co. KG
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Terminated		 JJENone listed
Apr 9, 2020The Binding Site Group, Ltd.
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to mea
Terminated		 JJENone listed
Apr 7, 2020Inpeco S.A.
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Apr 7, 2020Inpeco S.A.
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Apr 7, 2020Inpeco S.A.
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Feb 24, 2020Randox Laboratories, Limited
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analy
Terminated		 JJEK131554
Jan 24, 2020Abbott Gmbh & Co. KG
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Terminated		 JJENone listed
Oct 22, 2019Biomerieux Inc
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Terminated		 JJEK141133
Sep 23, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer
Terminated		 JJEK151767
Sep 16, 2019Abbott Gmbh & Co. KG
Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Open, Classified		 JJENone listed
Sep 16, 2019Abbott Gmbh & Co. KG
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
Open, Classified		 JJENone listed
Sep 16, 2019Abbott Gmbh & Co. KG
Alinity ci Level Sensor, Bulk Solution
Open, Classified		 JJENone listed
Aug 15, 2019Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Terminated		 JJEK151792
Aug 15, 2019Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Terminated		 JJEK151792
Jul 18, 2019Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
Terminated		 JJEK160571
Jul 18, 2019Roche Diagnostics Operations, Inc.
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Terminated		 JJEK100853
Jul 18, 2019Roche Diagnostics Operations, Inc.
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Terminated		 JJEK060373
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Terminated		 JJEK063144
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer
Terminated		 JJEK063144
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer
Terminated		 JJEK063144
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 5600 Integrated System, clinical chemistry analyzer
Terminated		 JJEK081543
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 5600 Integrated System, clinical chemistry analyzer
Terminated		 JJEK081543
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 350 Chemistry System, clinical chemistry analyzer
Terminated		 JJEK922072
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 250AT Chemistry System, clinical chemistry analyzer
Terminated		 JJEK922072
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Terminated		 JJEK922072
Jul 8, 2019Ortho Clinical Diagnostics
VITROS 250 Chemistry System, clinical chemistry analyzer
Terminated		 JJEK922072
Jun 24, 2019Randox Laboratories, Limited
RX Imola, Model Nos. RX4900
Terminated		 JJEK052914
Jun 24, 2019Randox Laboratories, Limited
RX Daytona, Model Nos. RX4040 and RX4041
Terminated		 JJEK131554
Jun 10, 2019Abbott Gmbh & Co. KG
Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and im
Terminated		 JJENone listed
May 21, 2019Abbott Gmbh & Co. KG
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL
Terminated		 JJENone listed
May 17, 2019Beckman Coulter Inc.
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Terminated		 JJEK140496

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