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Specimen Collection Kit For The Fetal Fibronectin Test
Brand(s)
Summary
Customers to be notified. Instructions to be provided to stop using and dispose of affected units.
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
Hologic, Inc.
10210 Genetic Center Drive, San Diego, California, United States, 92121
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