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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAPID ANTIGEN TEST SALIXIUM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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RAPID ANTIGEN TEST SALIXIUM CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 202110226
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem Insufficient Information (4580)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
I was testing myself for covid as my husband had it. I used the "covid-19 rapid antigen test, saliva/nasal swab samples" kit by salixium, made in malaysia. After i put the swab in the tube, the first one didn't have enough liquid in it to test. The second one didn't have enough liquid either before i put the swab in the tube. I have the third test unopened. It also doesn't have enough liquid. It is lot number 202110226, exp 2023/04, ref slxhb1-0621001. This product is distributed by (b)(4). Fda safety report id# (b)(4).
 
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Brand NameRAPID ANTIGEN TEST SALIXIUM
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key15066859
MDR Text Key296299115
Report NumberMW5110962
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/18/2022
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number202110226
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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