MEDLINE
Received Apr 3, 2026 · Event occurred Mar 19, 2026
Report 1417592-2026-00289 · MDR key 24774443
Device
Generic name
Test,mono,cass,25 Test
Manufacturer
Medline Industries, LpCatalog number
MPH50025M
Lot number
225B11
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY, ON (B)(6) 2026, "WE TESTED A PATIENT (SERUM) WHO TESTED POSITIVE (WEAK) IN THE CARDINAL KIT X2 AND COMPLETELY NEGATIVE X2 IN THE MEDLINE KIT." THE CARDINAL KIT WAS USED INSTEAD TO CONFIRM THE POSITIVE TEST. THE PATIENT IS DOING "FINE" AS THE CARDINAL KIT SHOWED THE POSITIVE RESULT, SO THE PATIENT RECEIVED APPROPRIATE TREATMENT.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, ON (B)(6) 2026, "WE TESTED A PATIENT (SERUM) WHO TESTED POSITIVE (WEAK) IN THE CARDINAL KIT X2 AND COMPLETELY NEGATIVE X2 IN THE MEDLINE KIT." THE CARDINAL KIT WAS USED INSTEAD TO CONFIRM THE POSITIVE TEST. THE PATIENT IS DOING "FINE" AS THE CARDINAL KIT SHOWED THE POSITIVE RESULT, SO THE PATIENT RECEIVED APPROPRIATE TREATMENT. NO MEDICAL INTERVENTION, SERIOUS INJURY, OR FOLLOW-UP CARE HAS BEEN REPORTED. 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 MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.