ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY 02G23-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-29 for ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY 02G23-25 manufactured by Abbott Ireland.

MAUDE Entry Details

Report Number3008344661-2019-00059
MDR Report Key8561550
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-04-29
Date of Report2019-07-31
Date of Event2019-03-31
Date Mfgr Received2019-07-30
Device Manufacturer Date2018-06-07
Date Added to Maude2019-04-29
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 ContactCHRISTIAN LEE
Manufacturer Street100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224668-294
Manufacturer G1ABBOTT IRELAND
Manufacturer StreetDIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK
Manufacturer CitySLIGO NA
Manufacturer CountryEI
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT HBSAG QUALITATIVE II CONFIRMATORY
Generic NameHBSAG CONFIRMATORY
Product CodeKSJ
Date Received2019-04-29
Catalog Number02G23-25
Lot Number87248FN00
Device Expiration Date2019-03-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT IRELAND
Manufacturer AddressDIAGNOSTICS DIVISION FINISKLIN BUSINESS PARK SLIGO NA EI NA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-29

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