MAUDE Adverse Event Report: I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD. I HEALTH COVID TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number IC03000 (?)

Device Problems Product Quality Problem (1506); Expiration Date Error (2528)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

Ordered covid test kits through the united states postal service on (b)(6) 2022.Received kits (2 different kits with 2 tests each) in the mail on (b)(6) 2022.All the test kits delivered to me, by the usps were expired.Is it legal to distribute expired covid test kits? will they work? they were also delivered in 100 + deg.Temps.Is there any temperature regulation for these kits? i health covid 19, antigen rapid test lot # 221c020214 best by 8/13/2022 and lot # 221c020121 best by 7/20/2022.Fda safety report id # (b)(4).

• Brand Name: I HEALTH COVID TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD.
• MDR Report Key: 15320591
• MDR Text Key: 298980958
• Report Number: MW5111761
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/13/2022
• Device Model Number: IC03000 (?)
• Device Lot Number: 221C020214
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female