Siemens Healthcare Diagnostics Inc. - Class 2 Recall
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics Inc. - Class 2 Recall
Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL 80 COOX SYSTEM - Class 2 Recall
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - CentraLink Data Management
System and Atellica Data Manager
(CentraLink/Atellica DM) - Class 2 Recall
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - CentraLink Data Management
System and Atellica Data Manager
(CentraLink/Atellica DM) - Class 2 Recall
(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Abbott Laboratories - Accelerator APS Aliquoter Module - Class 2 Recall
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX PLUS - Class 2 Recall
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - Aptio Automation System - Class 2 Recall
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - FlexLab Automation System - Class 2 Recall
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX - Class 2 Recall
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - Accelerator a3600 Automation System - Class 2 Recall
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2020 Category: Medical Devices Source Type: alerts
Thermo Fisher Scientific (Monterrey) - Samco BioTite Sterile Specimen Container - Class 2 Recall
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - FlexLab (aka Accelerator a3600 and Aptio Automation) - Class 2 Recall
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to aut...
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - Accelerator a3600 Automation System - Class 2 Recall
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in or...
Source: Medical Device Recalls - May 27, 2020 Category: Medical Devices Source Type: alerts
Inpeco S.A. - Inpeco SA - Class 2 Recall
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts
