MalfunctionKTN
MEDLINE
Received Jun 4, 2026 · Event occurred May 4, 2026
Report 1417592-2026-01995 · MDR key 25399672
Device
Generic name
Test,mono,cass,25 Test
Manufacturer
Medline Industries, LpCatalog number
MPH50025M
Lot number
225F11
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PRODUCT IS PRODUCING FALSE NEGATIVE RESULTS. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT IS PRODUCING FALSE NEGATIVE RESULTS.