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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 High Test Results (2457)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Correction/removal number
=
3002809144-03/16/20-002-r. Investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results. An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1. 00 - 1. 72 s/co have the potential to be falsely reactive. A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00. The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.
 
Event Description
The customer reported their negative quality control is intermittently out of range high with the abbott control while using the architect havab-g reagent. There was no patient involvement and no reported impact to patient management.
 
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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 Key9896131
MDR Text Key189497293
Report Number3002809144-2020-00226
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
Report Date 03/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2020
Device Model Number6L27-25
Device Catalogue Number06L27-25
Device Lot Number08073BE00
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 Received03/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2019
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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