Hologic, Inc. is recalling approximately 1,351 Rapid fFN Specimen Collection kits because the included transport tubes may be empty or have incorrect levels of extraction buffer. These kits are used by healthcare professionals to collect samples that help determine the risk of preterm delivery in pregnant individuals. No incidents or injuries have been reported at this time.
Incorrect buffer levels in the collection tubes can cause the testing system to produce invalid results, false positives, or false negatives. This could lead to unnecessary medical interventions or a failure to provide necessary care for patients at risk of preterm delivery.
The Collection Tube (PN: 71550-001) is a component of the Specimen Collection kit (PN: 71738-001). Tubes were manufactured by MML Diagnostics Packaging and packaged by Hologic.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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