Home / Recalls / Hologic, Inc. / Z-0694-2025

Z-0694-2025 Class II Ongoing

Recalled by Hologic, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
January 1, 2025
Initiation Date
November 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

Product Description

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

Reason for Recall

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

Distribution Pattern

US: AK

Code Information

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

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  • Z-3248-2024 Class II — Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version D (August 19, 2024)
  • Z-2373-2024 Class II — Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-W (June 13, 2024)
  • Z-1733-2024 Class I — BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking (March 13, 2024)
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