Hologic, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0694-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: January 1, 2025

Recall Number: Z-0694-2025

Event ID: 95731

Reason for Recall:

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

Status: Ongoing

Product Quantity: 3

Code Information:

UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494

Distribution Pattern:

US: AK

Voluntary or Mandated:

Voluntary: Firm initiated