MalfunctionQKP
COVID-19 AT-HOME TEST PILOT
Received May 26, 2023
Report MW5117944 · MDR key 17019747
Device
Generic name
Coronavirus Antigen Detection Test System
Manufacturer
Sd Biosensor, Inc.Lot number
53K38N5T1
Product problems
- Microbial Contamination of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED A LETTER FROM THE FDA ADVISING US TO THROW AWAY OUR TESTS BECAUSE OF A BACTERIA CONTAMINATED COVID 19 PILOT TEST. WE WERE TOLD TO ALSO CONTACT YOU FOR FURTHER DIRECTIONS.