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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Catalog Number 06C30-74
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, list number (b)(4), that has a similar product distributed in the us, list number (b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. All available patient information was included. Additional patient details are not available.
 
Event Description
The customer stated that a (b)(6) architect (b)(6) result of 0. 47 s/co was generated for a patient sample (<0. 80 s/co is negative). The sample was weakly positive using an elisa method (not specified). A new sample was collected from the patient and the architect (b)(6) result was 0. 39 s/co. No adverse impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-M 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 Key10861892
MDR Text Key240116791
Report Number3002809144-2020-01122
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2020
Device Catalogue Number06C30-74
Device Lot Number12568BE01
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 Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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