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Health Canada Medical devices

Specimen Collection Kit For The Fetal Fibronectin Test

Issued January 22, 2025
Issue
Four rapid FFN specimen collection kits were rejected by the in-line pouch weigher due to a variance in extraction buffer fill volumes in the specimen collection tubes. The tubes (PN: 71550-001) LN 885005 were kitted in two different kits (PN: 71738-001) with LN 901164 and LN 901165. Recall Start Date: December 20, 2024
Hazard description
Performance
Product
Product name
Specimen Collection Kit For The Fetal Fibronectin Test
Reference
ID
RA-76845