Z-0694-2025Class II

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

Name: Z-0694-2025 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Creator: Hologic, Inc.
Published: 2024-11-08
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2024-11-08 / Open, Classified

FDA source

Hologic, Inc. began a recall of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 on 2024-11-08. FDA classified it as Class II and gives the reason as "SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0694-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-08
Posted: 2024-12-20
Recalling firm: Hologic, Inc.
Product: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Product code: QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Reason for recall: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
FDA root cause: Unknown/Undetermined by 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]
Quantity in commerce: 3
Distribution: US: AK
Product codes and lots: UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0694-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code QOF

K222736Class IIPanther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. / cleared 2023-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)