Specimen Collection Kit For The Fetal Fibronectin Test
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Specimen Collection Kit For The Fetal Fibronectin Test | 901164 | 71738-001 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Hologic, Inc.
10210 Genetic Center Drive, San Diego, California, United States, 92121
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76845
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