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U.S. Department of Health and Human Services

Class 2 Device Recall Panther Fusion System

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  Class 2 Device Recall Panther Fusion System see related information
Date Initiated by Firm December 15, 2023
Date Posted January 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-0782-2024
Recall Event ID 93593
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product PANTHER FUSION System REF 9121010000


The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.
Code Information Fusion System Part Number: ASY-09600 UDI Code: Pending Serial Numbers Panther / Fusion: 1010910036 2101000822 1010910056 2101000883 1010910064 2101000783 1010910075 2101000786 1010910111 2101000654 1010910171 2101000961 1010910195 2101000810 1010910216 2101000866 1010910220 2101000500 1010910343 2101000779 1010910389 2101000901 1010910453 2101000900 1010910461 2101000675 1010910470 2101000645 1010910504 2101000674 1010910544 2101000703 1010910551 2101001001 1010910571 2101000837 1010910647 2101000893 1010910649 2101000712 1010910672 2101000760 1010910686 2101000979 1010910690 2101000775 1010910691 2101000778 1010910716 2101000845 1010910731 2101000827 1010910732 2101000831 1010910733 2101000807 1010910789 2101000858 1010910790 2101000859 1010910795 2101000879 1010910821 2101000894 1010910824 2101000916 1010910825 2101000917 1010910826 2101000919 1010910837 2101000846 1010910856 2101000939 1010910877 2101000947 2090000355 2101000218 2090000527 2101000791 2090000585 2102100927 2090000617 2101000355 2090000747 2101000655 2090000798 2101000344 2090000896 2101000885 2090000902 2101000918 2090000909 2101000236 2090000959 2101000414 2090000996 2101000334 2090001017 2101000834 2090001099 2101000079 2090001309 2101000083 2090001393 2101000214 2090001410 2101000119 2090001424 2101000324 2090001550 2101000889 2090001556 2101000973 2090001591 2101000075 2090001656 2101000860 2090001700 2101000902 2090001740 2101000888 2090001780 2101000994 2090001786 2101000139 2090001860 2101000577 2090001871 2101000616 2090001872 2101000173 2090001886 2101000310 2090002308 2101001008 2090002339 2101000128 2090002341 2101000376 2090002447 2101000374 2090002462 2101000777 2090002487 2101000459 2090002530 2101000785 2090002551 2101000231 2090002572 2101000136 2090002692 2101000273 2090002730 2101000342 2090002742 2101000312 2090002768 2101000833 2090002798 2101000118 2090002810 2101000895 2090002824 2101000248 2090002847 2101000225 2090002911 2101000773 2090002964 2101000252 2090002969 2101000890 2090002976 2101000816 2090003009 2101000474 2090003024 2101000993 2090003100 2101000821 2090003101 2101000830 2090003110 2101000946 2090003126 2101000288 2090003170 2101000670 2090003245 2101000865 2090003248 2101000285 2090003314 2101000333 2090003315 2101000341 2090003318 2101000353 2090003326 2101000308 2090003358 2101000360 2090003379 2101000817 2090003384 2101000820 2090003390 2101000715 2090003394 2101000792 2090003415 2101000343 2090003456 2101000350 2090003540 2101000397 2090003551 2101000418 2090003553 2101000385 2090003555 2101000403 2090003556 2101000608 2090003574 2101000421 2090003658 2101000440 2090003672 2101000716 2090003674 2101000451 2090003739 2101000835 2090003805 2101000829 2090003818 2101000480 2090003819 2101000482 2090003820 2101000794 2090003822 2101000468 2090003922 2101000823 2090003941 2101000793 2090004065 2101000579 2090004138 2101000705 2090004188 2101000656 2090004224 2101000824 2090004229 2101000825 2090004299 2101000795 2090004300 2101000796 2090004389 2101000782 2090004412 2101000808 2090004414 2101000891
Recalling Firm/
Manufacturer		 Hologic, Inc.
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Ryan Simon
858-275-0032 Ext. 128
Manufacturer Reason
for Recall		 Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 12/15/2023, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx 2-day delivery to customer informing them that the firm has became aware of potential erroneous influenza B virus (FLU B) positive results when testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay on the Panther Fusion System. Customers are instructed to: 1. They may continue to test with the Panther Fusion SARS-CoV-2/Flu A/B/RTSV assay on the Panther Fusion System. 2. Hologic has partnered with Novasyte, an IQVIA MedTech company, to assist in the recall. Acknowledge receipt of the notification by completing the Customer Acknowledgement Form located at https;//iqvia-response.my.site.com/mt/fca?cid=HPAN23 3. To ensure visibility of the issue, Hologic recommends posting the notification on or near the Panther Fusion Systems that are running the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. 4. If customers suspect a false Flu B positive result in combination with SARS-CoV-2 positive result (dual positive), contact Hologic Technical Support for evaluation and/or troubleshooting. For questions or assistance, contact Hologic Technical Support. Country-specific telephone and email contact information for Technical Support can be found at www.hologic.com/support.
Quantity in Commerce 771 systems (of which 313 are potentially impacted)
Distribution Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, UT, VA, VI, WA, WI, and WV. The countries of Austria, Australia, Belgium, Dominican Republic, Switzerland, Germany, Denmark, Spain, France, Great Britain, Hong Kong, Ireland, Italy, Korea, Kuwait, The Netherlands, Norway, New Zealand, Portugal, Qatar, and Sweden.
Total Product Life Cycle TPLC 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.
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