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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGG IGG ANTI-HAV

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ABBOTT GMBH ARCHITECT HAVAB-IGG IGG ANTI-HAV Back to Search Results
Catalog Number 06C29-27
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2019
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27. Patient information: no specific patient information is available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false reactive architect havab igg results for one patient. The patient was previously negative, has not been vaccinated and has no symptoms for hepatitis a. Additionally, the sample was negative for havab igm. No impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-IGG
Type of DeviceIGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9317950
MDR Text Key219783173
Report Number3002809144-2019-00869
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/29/2020
Device Catalogue Number06C29-27
Device Lot Number06164BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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