MAUDE Adverse Event Report: BIOCAN DIAGNOSTICS INC. TELL ME FAST NOVEL CORONAVIRUS (COVID-19) IGG/IGM AB TEST CASSETTE B251C; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem Missing Test Results (3267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2020

Event Type  malfunction  

Event Description

Received no result on an antibody test that is advertising itself as fda approved.Seems to be fake, made in (b)(6) but disguising itself as made in (b)(6).Fda safety report id# (b)(4).

• Brand Name: TELL ME FAST NOVEL CORONAVIRUS (COVID-19) IGG/IGM AB TEST CASSETTE B251C
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): BIOCAN DIAGNOSTICS INC.
• MDR Report Key: 10137613
• MDR Text Key: 194772941
• Report Number: MW5094905
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR