FDA Device recall Z-0782-2024
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necess…
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necess… by Hologic, citing due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0782-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-15 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hologic |
| Distribution | US |
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.
Reason
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Identifiers
| code_info | Fusion System Part Number: ASY-09600 UDI Code: Pending Serial Numbers Panther / Fusion: 1010910036 2101000822 1010910…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 20900006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0782-2024%22
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