Mnisure Rom Test (2020-03-24)
AmniSure ROM Test Recall Summary The AmniSure ROM Test, a medical device used to detect rupture of amniotic membranes during pregnancy, was recalled across Canada in March 2020. The recall was classified as Class I, indicating a serious safety concern. The device was distributed to healthcare facilities and healthcare providers nationwide.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-04-15
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2cff6688-5298-4e65-941f-c0744b5b1967