8,827 results
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50ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 2, 2023
BD PHOENIX¿ PMIC/ID-106
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 26, 2024
BD MAX¿ ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·April 18, 2023
IH-COM V5.0
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·April 25, 2025
ISOLEX 300I V2.5 DISPOSABLE SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code MZK·August 8, 2005
BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·October 3, 2023
BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHR·August 13, 2024
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·Product code JTC·February 12, 2010
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·December 29, 2009
DRIED POS MIC PANEL TYPE 20A
FDA Adverse Event
Malfunction
·DADE BEHRING INC.·Product code LTT·November 9, 2005
DRIED POS COMBO TYPE 21
FDA Adverse Event
Malfunction
·DADE BEHRING, INC.·Product code LTT·November 9, 2005
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·July 11, 2012
ID-MTS A/B/D MONOCLONAL BLOOD GROUPING CARD
FDA Adverse Event
Other
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·October 23, 2002
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
TANGO OPTIMO
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·July 23, 2012
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·June 17, 2010
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 16, 2011
CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS
FDA Adverse Event
Malfunction
·CEPHEID·Product code QJR·December 27, 2023
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