Specimen Collection Kit For The Fetal Fibronectin Test

Specimen Collection Kit For The Fetal Fibronectin Test Recall A specimen collection kit used to test for fetal fibronectin (a protein that may indicate premature birth risk) is being recalled across Canada due to performance issues. The kit may not work as intended, which could affect the accuracy of test results. This is a Class I recall, indicating a serious safety concern.

Product
Specimen Collection Kit For The Fetal Fibronectin Test
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-01-22
Status
Closed
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bca1b2d2-81eb-4a6b-b9d6-a407070d1e4c