22 results
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21ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJQ·October 3, 2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
MicroScan WalkAway-96 plus Instrument REF B1018-284
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code LRG·October 21, 2019
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·September 10, 2015
MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·September 10, 2015
MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code OUG·July 17, 2015
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.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code OUG·October 25, 2016
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LTT·July 24, 2025
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·December 1, 2015
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·December 1, 2015
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·December 1, 2015
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTT·March 6, 2013
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·December 1, 2015
MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LTT·December 1, 2015
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LIE·December 13, 2019
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LRG·December 2, 2020