MalfunctionNQM
Amnisure
Received Jul 28, 2026 · Event occurred Jun 29, 2026
Report 50053835 · MDR key 50053835
Device
Generic name
Immunoassay, Placental Alpha-1 Microglobulin (pamg-1)
Manufacturer
Qiagen Sciences LlcCatalog number
FMRT-1-25-US
Lot number
581011354
Product problems
- Break
- Unraveled Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Amnisure swabs are unwinding and falling apart when they get wet, either in the patient or in the solution.This potentially could cause an inaccurate test which may affect the diagnosis for the patient.Swap was discarded.