• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN 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
 

ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number CP21K11
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 01/23/2022
Event Type  malfunction  
Event Description
I bulk ordered 100 of the on/go branded covid-19 antigen test kits produced by accessbio and distributed by (b)(4) for use by my office. We received the 100 kits all from the same lot # cp21k11. In one of the kits we found what appeared to be a bug or some sort of brown particulate floating in the unopened extraction media vial. When we opened the rest of the kits all the unopened extraction media vials appeared to be cloudy, with some containing what appears to be some sort of precipitate in the media and up the sides of the vial. I am unable to find a clear picture of what the extraction media should look like, but the range of differences in the media in one lot is concerning. The media vials were taken from sealed kits that were left at ambient temperature inside a cabinet in an office building. They hadn't been moved or shaken recently. I've attached pictures of several different vials, including the one with the brown particulate. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameON/GO COVID-19 ANTIGEN TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ACCESS BIO INCORPORATE
MDR Report Key13385291
MDR Text Key284829081
Report NumberMW5107034
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00860006191665
UDI-Public(01)00860006191665
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 01/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Lot NumberCP21K11
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

-
-