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U.S. Department of Health and Human Services

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

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SD BIOSENSOR "COVID-19 AT-HOME TEST" CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 07/21/2022
Event Type  Injury  
Event Description
The covid-19 at-home tests i received (and have used) through the federal free test program via the u. S. Postal service are not listed as an authorized/approved eua product on the fda's web site list of 22 products (as of checking five times today on the fda. Gov web site. This list claims to be updated as of yesterday. This is either criminal, life-threatening fraud, of a failure of the fda to properly maintain and update its web page pertaining to this list of products. I have already used a box and half, i believe, of this product. If these tests are not authorized, then my health and safety, as well as that of others and those whom i have come into contact with, has been endangered during a life-and-death pandemic. This needs immediate attention. The product i received visually appears in none of the photos shown on your web site list. The product name nor distributor name (b)(4) does not appear in the list. The manufacturer, after much hunting on my product, is listed as sb biosensor, but the only product on the fda authorized list bears a different name and image. The reason i happened to stumble upon on this serious flaw today is because of news reports on these types of tests expiring and some receiving new extension dates. Nothing resembling the box i received called "covid-19 at-home test" in a blue and white box appears as of today 3:30 p. M. Central time on your web site. You need to find out if these have been distributed illegally or if not, update your web site accordingly because i can assure you this is an alarming problem either way for people trying to live through a pandemic, particularly senior citizens with health issues such as myself. I have notified my u. S. Senators office. I look forward to your response. At a minimum, this is extremely sloppy work; at worst, you have endangered lives. Fda safety report id# (b)(4).
 
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Brand Name"COVID-19 AT-HOME TEST"
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
SD BIOSENSOR
MDR Report Key15103829
MDR Text Key296687778
Report NumberMW5111093
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage

Patient Treatment Data
Date Received: 07/25/2022 Patient Sequence Number: 1
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