Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Microbiology · 21 CFR 866.1640
Recent MDR events
137 adverse event reports on file
- DXM 1040 MICROSCAN WALKAWAYFeb 13, 2025DeathBeckman Coulter1061932-2025-00018
- DXM 1096 MICROSCAN WALKAWAY INSTRUMENTOct 3, 2024MalfunctionBeckman Coulter Inc.1061932-2024-00014
- DXM 1040 MICROSCAN WA INSTRUMENTJun 2, 2020MalfunctionBeckman Coulter2919016-2020-00001
- WALKAWAY96 PLUSNov 6, 2019InjuryBeckman Coulter2919016-2019-01002
- WA96 PLUS GENERICAug 8, 2019InjuryBeckman Coulter2919016-2019-01001
- WALKAWAY-40 SIAug 5, 2019InjuryBeckman Coulter2919016-2019-01000
- WALKAWAY-40 SIMar 14, 2017MalfunctionBeckman Coulter2919016-2017-00004
- LAB PRO MBTAug 22, 2016InjuryBeckman Coulter, Inc.MW5064331
- WALK AWAY 40 PLUSNov 18, 2015InjuryBeckman Coulter2919016-2015-00111
- WALKAWAY 96 PLUSAug 25, 2015MalfunctionBeckman Coulter2919016-2015-00106
Event type breakdown
Recalls
13 recall events for this product code
- Remel, IncOpen, ClassifiedMar 19, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Z-1395-2025 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedJul 2, 2014
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge.
Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
Z-1990-2014 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapid
Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.
Z-0720-2021 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
MicroScan WalkAway-40 plus Instrument REF B1018-283
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1083-2022 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
MicroScan WalkAway-96 plus Instrument REF B1018-284
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1084-2022 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1085-2022 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1086-2022 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1087-2022 · View FDA record ↗ - Beckman Coulter Inc.Open, ClassifiedUnknown
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Z-1088-2022 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
MicroScan WalkAway-40 plus Instrument
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Z-1370-2021 · View FDA record ↗
Registered firms
127 firms currently registered for this product code
510(k) clearances
45 clearances for this product code
- Thermo Fisher ScientificNov 6, 2019
K191918 · Thermo Scientific Sensititre ARIS HiQ System
- Thermo Fisher ScientificNov 6, 2019
K191914 · Thermo Scientific Sensititre ARIS HiQ System
- Trek Diagnostic Systems, Ltd.Sep 22, 2011
K110583 · SENSITITRE OPTIREAD
- Trek Diagnostic SystemsAug 26, 2011
K103532 · AUTOREADER 2
- Siemens Healthcare Diagnostics, Inc.Aug 4, 2011
K111677 · MICROSCAN(R) MICROSTREP PLUS(R)
- Siemens Healthcare Diagnostics, Inc.Jul 20, 2011
K111205 · MICROSCAN (R) MICROSTREP PLUS (R) PANELS
- Siemens Healthcare DiagnosticsSep 10, 2010
K101425 · MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- Siemens Healthcare DiagnosticsSep 8, 2008
K081013 · MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN