Hologic Rapid fFN Specimen Collection Tubes May Contain Incorrect Extraction Buffer Volumes
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. No illnesses or injuries have been reported. However, the defect directly impacts diagnostic accuracy—false positive results could lead to unnecessary clinical interventions, while false negative results could cause missed diagnoses. This risk-of-harm scenario without reported adverse events meets the criteria for High severity.
Plain-English summary
Three lots of Hologic Rapid fFN Specimen Collection Tubes (lots 901164, 901165, and 904850) are the subject of this recall. These tubes are components of the Rapid fFN Specimen Collection kit and are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN system to assess the risk of preterm delivery. The recalled tubes may contain empty, underfilled, or overfilled extraction buffer.
Incorrect buffer volumes compromise test reliability. Empty or underfilled tubes may yield invalid results or cause testing delays. Underfilled tubes may produce false positive results, while overfilled tubes may produce false negative results. Such diagnostic errors could affect the accuracy of preterm delivery risk assessment.
A total of 1,351 units were distributed worldwide, including throughout the United States (all 50 states plus Guam) and internationally to Canada and Japan.
The recalled product
- Product
- The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extr
- Manufacturer
- Hologic, Inc.
- Hazard
- invalid-results
- false-positive
- false-negative
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 901164
- 901165
- 904850/ UDI: 25420045514765
Distribution
Distributed nationwide across the United States.
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