ALINITY S SYSTEM 06P1601 06P16-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for ALINITY S SYSTEM 06P1601 06P16-01 manufactured by Abbott Manufacturing Inc.

MAUDE Entry Details

Report Number1628664-2020-00081
MDR Report Key9843263
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-07-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2016-12-21
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 MANUFACTURING INC
Manufacturer Street1921 HURD DRIVE
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameALINITY S SYSTEM
Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Product CodeMZA
Date Received2020-03-17
Model Number06P1601
Catalog Number06P16-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MANUFACTURING INC
Manufacturer Address1921 HURD DRIVE IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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