• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SD BIOSENSOR, INC. COVID-19 AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 09666672160
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: occupation is patient/consumer. The case has been sent to the manufacturer for investigation. The investigation is ongoing.
 
Event Description
The consumer initially called for assistance on how to perform the covid-19 at-home test. The consumer then alleged that the box label with the lot number and expiration date was missing from the packaging for the covid-19 at-home test. No other information can be provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key14268833
MDR Text Key299495045
Report Number1823260-2022-01239
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,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09666672160
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/18/2022
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

-
-