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U.S. Department of Health and Human Services

Class 2 Device Recall Panther Fusion SARSCoV2/Flu A/B/RSV Assay

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 Class 2 Device Recall Panther Fusion SARSCoV2/Flu A/B/RSV Assaysee related information
Date Initiated by FirmNovember 08, 2024
Date PostedDecember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0694-2025
Recall Event ID 95731
510(K)NumberK222736 
Product Classification Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
ProductPanther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Code Information UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494
Recalling Firm/
Manufacturer		 Hologic, Inc.
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact
408-745-0975 Ext. 128
Manufacturer Reason
for Recall		SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 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 molecularsupport@hologic.com If you require technical support, contact the firm's Technical Support at 1-888-484-4747, or 1-858-410-8511, or molecularsupport@hologic.com
Quantity in Commerce3
DistributionUS: AK
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QOF
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