MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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).

• Brand Name: ON/GO COVID-19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 13385291
• MDR Text Key: 284829081
• Report Number: MW5107034
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00860006191665
• UDI-Public: (01)00860006191665
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Lot Number: CP21K11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Patient Sequence Number: 1