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U.S. Department of Health and Human Services

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

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ABBOTT GMBH ARCHITECT HAVAB-G IGG ANTI-HAV Back to Search Results
Model Number 6L27-25
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient information has been included. No additional patient details are available. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false reactive havab-g results when processing on the architect i2000sr. No specific patient data was provided. No impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-G
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 Key9189370
MDR Text Key189743247
Report Number3002809144-2019-00619
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113704
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/04/2020
Device Model Number6L27-25
Device Catalogue Number06L27-25
Device Lot Number06172BE00
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 Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction Number3002809144-03/16/20-002-

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