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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SD BIOSENSOR, INC. COVID-19 AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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SD BIOSENSOR, INC. COVID-19 AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 09666672160
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2022
Event Type  malfunction  
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Brand NameCOVID-19 AT-HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
SD BIOSENSOR, INC.
c-4th&5th,16, deogyeong-daero
1556beon-gil, yeongtong-gu
suwon-si, gyeonggi-do 16690
KS 16690
Manufacturer (Section G)
SD BIOSENSOR, INC.
c-4th&5th,16, deogyeong-daero
1556beon-gil, yeongtong-gu
suwon-si, gyeonggi-do 16690
KS 16690
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key15322806
Report Number1823260-2022-02644
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210661
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2022
Device Catalogue Number09666672160
Device Lot Number53K3321T11
Was Device Available for Evaluation? No
Date Manufacturer Received08/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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