inforMED
MalfunctionQKO

WONDFO BIOTECH CO. SARS-COV-2 ANTIBODY TEST

Received May 27, 2020 · Event occurred Apr 28, 2020

Report MW5094699 · MDR key 10095869

Device

Generic name

Reagent, Coronavirus Serological

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

46 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

I RECEIVED A WONDFO BIOTECH RAPID ANTIBODY TEST AND THE RESULTS OF THE TEST ARE NOT RELIABLE. THE OFFICE PROVIDED INFORMATION THAT WAS NOT ACCURATE ABOUT THE SPECIFICITY AND SENSITIVITY OF THE TEST. IT HAS SINCE BEEN DETERMINED TO BE UNRELIABLE IN THE (B)(6). FDA SAFETY REPORT ID # (B)(4).