Recall Monitor
Health Products

Specimen Collection Kit For The Fetal Fibronectin Test

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: Specimen Collection Kit For The Fetal Fibronectin Test
Issue: Medical devices - Performance
What to do: Customers to be notified. Instructions to be provided to stop using and dispose of affected units.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Specimen Collection Kit For The Fetal Fibronectin Test90116471738-001

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

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