Official recall record
Specimen Collection Kit For The Fetal Fibronectin Test
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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