Recall Z-0782-2024 ยท OOI Real Time Nucleic Acid Amplification System
Hologic, Inc.
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 nuclei
| Date | Jan 23, 2024 (initiated Dec 15, 2023) |
| Status | Open, Classified |
| Reason | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| Root cause | 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 compl |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.