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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HAVAB-IGG REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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ABBOTT GMBH ALINITY I HAVAB-IGG REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Catalog Number 08P26-22
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product list 8p26, that has a similar us product distributed in the us, list 8p27. An evaluation is in process. A followup report will be submitted when the evaluation is complete.
 
Event Description
The account observed false reactive alinity i havab igg values between 1 to 2 s/co on samples that repeat reactive but when a new sample is obtained a negative result is generated. The patients are hiv positive that come to the lab for routine vaccination. No specific patient information was provided. No impact to patient management was reported.
 
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Brand NameALINITY I HAVAB-IGG REAGENT KIT
Type of DeviceHEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
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, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11071926
MDR Text Key223608187
Report Number3002809144-2020-01208
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
PMA/PMN Number
K113704
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 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/29/2021
Device Catalogue Number08P26-22
Device Lot Number16126BE00
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 Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/24/2020 Patient Sequence Number: 1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, AI01890
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