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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT HEPATITIS IGG TEST HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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ABBOTT LABORATORIES ARCHITECT HEPATITIS IGG TEST HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Abbott architect hepatitis a igg gave (b)(6) results on five pt samples. Abbott notified us of this possibility on wednesday march 11, 2020. We had been using affected lots of product dating back to (b)(6) 2019. Fda safety report id# (b)(4).
 
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Brand NameARCHITECT HEPATITIS IGG TEST
Type of DeviceHEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
Manufacturer (Section D)
ABBOTT LABORATORIES
MDR Report Key9853329
MDR Text Key184481036
Report NumberMW5093838
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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