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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MY LAB BOX HSV 2 TEST KIT; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY

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MY LAB BOX HSV 2 TEST KIT; HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY Back to Search Results
Patient Problems Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Suicidal Ideation (4429)
Event Date 04/04/2024
Event Type  malfunction  
Event Description
I ordered an std test kit from my lab box which includes an hsv 2 test.I got positive with no index number.It took me 4 days for them to email me the index number.I think they hid it and are banking on customers' ignorance.Several people on trust pilot have had the same experience.Their website says once you test positive for hsv 2 there is no need to retest.After reading the fda and cdc websites and going on reddit deep dives i learned about false positives.The assigned physician was eager to prescribe me medication and told me the test was 90% accurate.Not true.I was depressed and suicidal for 10 days until i got a follow-up test at (b)(6) that confirmed i did not have hsv2.I do not believe my lab box should be selling this test as i have recently learned that it is not a part of the regular std panel because of the psychological damage a false positive can cause.They are clearly in it for the money and not for the client's well-being.I lost (b)(6) dollars, sleep, and weight from not eating due to this misinformation and carelessness.I do not want this to happen to anyone else.Please make them remove this test from their website asap.
 
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Brand Name
MY LAB BOX HSV 2 TEST KIT
Type of Device
HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY
MDR Report Key19142185
MDR Text Key340573817
Report NumberMW5153978
Device Sequence Number1
Product Code OQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Patient Sequence Number1
Treatment
UBER BOX
Patient Outcome(s) Other;
Patient Age33 YR
Patient SexFemale
Patient Weight77 KG
Patient RaceBlack Or African American
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