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U.S. Department of Health and Human Services

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

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ABBOTT GERMANY ARCHITECT HAVAB-IGG IGG ANTI-HAV Back to Search Results
Catalog Number 06C29-22
Device Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2019
Event Type  malfunction  
Manufacturer Narrative
No customer returns were available. Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue. Complaint searches determined that there is slight elevated complaint activity for the likely cause lot. Labeling was reviewed and found to be adequate. Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified. Based on the available information, no product deficiency was identified.
 
Event Description
The customer observed (b)(6) architect havab-igg results while using reagent lot 01244be00. No specific data was provided. No adverse impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-IGG
Type of DeviceIGG ANTI-HAV
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
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 Key9412732
MDR Text Key213688194
Report Number3002809144-2019-01015
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2020
Device Catalogue Number06C29-22
Device Lot Number01244BE00
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 Received11/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2019
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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