Hologic, Inc.: Medical Device Recalls in 2025

According to to data from the FDA, there were 3 medical device recalls made by Hologic, Inc. in 2025. See the details of the recalls below.

You can see similar recalls for other firms.

• 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 extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
• Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
• Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400