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U.S. Department of Health and Human Services

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

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I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD. I HEALTH COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameI HEALTH COVID TEST KIT
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD.
MDR Report Key15320591
MDR Text Key298980958
Report NumberMW5111761
Device Sequence Number1
Product Code QKP
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 08/25/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date08/13/2022
Device Model NumberIC03000 (?)
Device Lot Number221C020214
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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