Public recall detail

Specimen Collection Kit For The Fetal Fibronectin Test

2025-01-22

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Recall Safety notice
Quick summary

Quick summary: Specimen Collection Kit For The Fetal Fibronectin Test. Date: 2025-01-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Specimen Collection Kit For The Fetal Fibronectin Test. Date: 2025-01-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHologic, Inc.
ProductSpecimen Collection Kit For The Fetal Fibronectin Test
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76845

Affected products

ProductSpecimen Collection Kit For The Fetal Fibronectin Test
Lot901164
Model71738-001
Serial number901164
DescriptionSpecimen Collection Kit For The Fetal Fibronectin Test

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

What you should do

  • Customers to be notified. Instructions to be provided to stop using and dispose of affected units.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Microbiology
CompaniesHologic, Inc. 10210 Genetic Center Drive, San Diego, California, United States, 92121
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76845
Background{}
CompaniesHologic, Inc. 10210 Genetic Center Drive, San Diego, California, United States, 92121
AudiencesHealthcare
Source updated2025-01-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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