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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 223CO20214
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 07/24/2022
Event Type  malfunction  
Event Description
Recently requested a batch of free covid tests from fda, received 4 boxes of ihealth covid-19 antigen rapid test, lot number 223co20214. Each tests comes with an empty collection tube and a sealed solution ampule. According to instructions, solution must reach at least first line in collection tube when filled, however ampule only contains enough solution to fill roughly half-way to line. Don't know if these tests were sent with inadequate amounts of solution, or if instructions are wrong, and only half as much solution is needed. Should i throw tests out? use them as with half solution? can i get extra solution or replacement tests, or am i out of luck? fda safety report id# (b)(4).
 
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Brand NameIHEALTH COVID-19 ANTIGEN RAPID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave
san jose CA 95131
MDR Report Key15112691
MDR Text Key296769168
Report NumberMW5111123
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 07/24/2022
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date08/13/2022
Device Lot Number223CO20214
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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