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

Lot Number 222CO20212

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

Covid-19 test card package had number "34" stamped on the packaging.Seemed unusual, maybe counterfeit? also, the manual has a line that ever so slightly juts out from the first example photo of a positive test in the manual.I got these tests from the usps recently, and i got no response last time from the manufacturer when helping a family member on a suspicious test, so i'm letting you know directly.Potentially counterfeit test? see photos and other notes.Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 14565780
• MDR Text Key: 293160815
• Report Number: MW5109998
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: 20856362005894
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/11/2022
• Device Lot Number: 222CO20212
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1