Beckman Coulter Inc. - MicroScan LabPro Data Management System - Class 2 Recall
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2016 Category: Medical Equipment Source Type: alerts
Cepheid - Xpert MRSA - Class 2 Recall
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2016 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - MicroScan LabPro Information Manager System - Class 2 Recall
MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073 LabPro MBT Connect Systems v4.30 Canada: 6000-0008 LabPro v4.41 Panel Update-06 Kit 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit 10638823 LabPro v4.11 Software Update Kit 10638825 LabPro v4.11 System Software 10638824 LabPro v4.11 Software...
Source: Medical Device Recalls - March 29, 2016 Category: Medical Equipment Source Type: alerts
Cepheid - Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit GXCT/NGSWAB50 - Class 3 Recall
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Cepheid - Xpert CT/NG Urine Specimen Collection Kit GXCT/NGSWAB50 - Class 3 Recall
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg/Urine Combo 51, B1017407 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - ESBL plus panel, B1027101 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg/Urine Combo 55, B1017409 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg Combo 50, B1017406 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg MIC 38, B1017412 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg/Urine Combo 61, B1017414 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
Beckman Coulter, Inc. - Microscan Neg Breakpoint Combo 47, B1017417 - Class 2 Recall
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2015 Category: Medical Equipment Source Type: alerts
SCC Soft Computer - SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. - Class 2 Recall
SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 10, 2014 Category: Medical Equipment Source Type: alerts
Medical Information Technology, Inc. - MEDITECH Microbiology - Class 2 Recall
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2014 Category: Medical Equipment Source Type: alerts
Biomerieux Inc - bioMerieux PREVI Isola System - Class 2 Recall
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2014 Category: Medical Equipment Source Type: alerts
