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

Lot Number (10):222CO20212

Device Problems Product Quality Problem (1506); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

Ihealth covid-19 antigen rapid test provided by the usps to all households.We received 8 kits of 2 tests each, however 5 of these kits had empty test liquid ampoules and therefore useless.The information on the boxes is as follows: gtin(01): (b)(4), lot no.(10):222co20212, use by (17):2022-08-11.Fda safety report id # (b)(4).

• Brand Name: COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 15310799
• MDR Text Key: 298874660
• Report Number: MW5111736
• Device Sequence Number: 9
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/24/2022
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: (10):222CO20212
• Patient Sequence Number: 1