LIQUID ASSAYED MULTIQUAL, LEVEL 1 694

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-09 for LIQUID ASSAYED MULTIQUAL, LEVEL 1 694 manufactured by Bio-rad Laboratories, Inc..

MAUDE Entry Details

Report Number2016706-2020-00006
MDR Report Key9806099
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-03-04
Date Mfgr Received2020-03-05
Device Manufacturer Date2017-03-31
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MARIA ZEBALLOS
Manufacturer Street9500 JERONIMO ROAD
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Manufacturer Phone9981200136
Manufacturer G1BIO-RAD LABORATORIES, INC.
Manufacturer Street9500 JERONIMO ROAD
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIQUID ASSAYED MULTIQUAL, LEVEL 1
Generic NameMUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
Product CodeJJY
Date Received2020-03-09
Model Number694
Catalog Number694
Lot Number45791
Device Expiration Date2020-03-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIO-RAD LABORATORIES, INC.
Manufacturer Address9500 JERONIMO ROAD IRVINE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-09

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