Hologic, Inc: Device Recall

Recall Details

Recall Number

Z-1170-2025

Classification

Class II

Product Type

Device

Recalling Firm

Hologic, Inc

Status

Ongoing

Date Initiated

01/15/2025

Location

Marlborough, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

55,335 units

Reason for Recall

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

Product Description

Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

Distribution Pattern

Domestic: Nationwide Distribution

Other Recalls by Hologic, Inc

• Class II: Risk 12/12/2025
  Fungal contamination of affected lot with Parengyodontium album.
• Class II: Risk 01/08/2025
  Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
• Class II: Risk 12/13/2024
  Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
• Class II: Risk 11/08/2024
  SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
• Class I: Dangerous 10/10/2024
  Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

View all recalls by Hologic, Inc →