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Open, Classified

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

FDA Recall Z-0694-2025 · Posted 2024-12-20

Recalling FirmHologic, Inc.
Recall StatusOpen, Classified
Product CodeQOF
Date Initiated2024-11-08
Product Quantity3

Reason for Recall

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

Firm Action

On 11/8/24, recall notices were mailed to customers asking them to do the following: 1) Discontinue use, and discard affected kits. 2) Complete and return the customer response firm via email to [email protected] If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or [email protected]

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US: AK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. · 2023-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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