379 results
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60ms
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Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JGS·November 19, 2025
VITROS CHEMISTRY PRODUCTS CREA SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JFY·June 27, 2022
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 22, 2010
EMBOSPHERE MICROSPHERES
FDA Adverse Event
Injury
·BIOSPHERE MEDICAL, S.A.·Product code NAJ·July 26, 2011
Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
FDA Enforcement
Class III
·Terminated·Lin-Zhi International Inc·December 4, 2013
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·April 10, 2008
I-STAT EG7+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CHL·March 15, 2011
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·September 3, 2020
VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·December 9, 2008
OXYSEPT
FDA Adverse Event
Injury
·PIRAMAL PHARMA LIMITED·Product code LPN·October 27, 2023
VITROS CHEMISTRY PRODUCTS CREA SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JFY·August 28, 2024
VITROS CHEMISTRY PRODUCTS CREA SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JFY·July 19, 2024
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS CHEMISTRY PRODUCTS NA+ SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JGS·September 12, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JLW·September 5, 2023