GTI PF4 ENHANCED KIT FOR DETECTION OF HEPARIN ANTIBODIES X-HAT13 OR X-HAT-45

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-27 for GTI PF4 ENHANCED KIT FOR DETECTION OF HEPARIN ANTIBODIES X-HAT13 OR X-HAT-45 manufactured by Gti.

Event Text Entries

[19950815] Different lots of this kit behave very different and results vary between.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW1035905
MDR Report Key754347
Date Received2005-06-27
Date of Report2005-06-27
Date Added to Maude2006-08-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameGTI PF4 ENHANCED KIT FOR DETECTION OF HEPARIN ANTIBODIES
Generic NameELISA KIT
Product CodeKFF
Date Received2005-06-27
Model NumberNA
Catalog NumberX-HAT13 OR X-HAT-45
Lot Number51304-HT45
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key742166
ManufacturerGTI
Manufacturer Address2095 CROSSROADS CIRCLE STE 200 WAUKESHA WI 531864054 US

Device Sequence Number: 2

Brand NameGTI PF4 ENHANCED KIT FOR DETECTION OF HEPARIN ANTIBODIES
Generic NameELISA KIT
Product CodeKFF
Date Received2005-06-27
Model NumberNA
Catalog NumberX-HAT13 OR X-HAT-45
Lot Number022805
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key742175
ManufacturerGTI
Manufacturer Address2095 CROSSROADS CIRCLE STE 200 WAUKESHA WI 531864054 US

Patients

Patient NumberTreatmentOutcomeDate
10 2005-06-27
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