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Specimen collection kit for the fetal fibronectin test

Official notice

22 Jan 2025

Last checked

22 Jan 2025

Medium riskHealth Canada
Watch Hologic

An official Health Canada notice concerns Specimen collection kit for the fetal fibronectin test. 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 Published 2025-01-22.

What to do now

Customers to be notified. Instructions to be provided to stop using and dispose of affected units.

Recall number

76845

Official notice

2025-01-22

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76845

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Affected products

Product 1

Affected products - Specimen Collection Kit For The Fetal Fibronectin Test, Lot or serial number - 901164, Model or catalog number - 71738-001

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Hologic, Specimen Collection Kit For The Fetal Fibronectin Test

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic, Specimen Collection Kit For The Fetal Fibronectin Test.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76845

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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