HOLOGIC INC
PANTHER FUSION · Chemistry
510(k) Clearances (8)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (8)
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Failed stability specifications for reagent kits that may result in false negative test results.
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
UDI Registrations (40)
Cytomegalovirus (CMV) Primers ASR.
BK virus (BKV) Probe ASR.
The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).
Varicella zoster virus (VZV) Primers ASR.
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, 96 tests.
Panther Fusion GI Expanded Bacterial Assay Controls Kit.
Specimen Transport Medium.
Hologic VZV Plasmid Control.
The DNA IC Primers ASR contains forward and reverse primers designed to amplify the DNA targets present in the Panther Fusion® Internal Control-S and Panther Fusion® Internal Control-X reagents.
Panther Fusion® Extraction Reagents-S.
Hologic EBV Plasmid Control.
The RNA IC Probe ASR contains an oligonucleotide designed to detect the RNA target present in the Panther Fusion® Internal Control-S reagent.
Epstein-Barr virus (EBV) Primers ASR.
Panther Fusion GI Bacterial Assay Controls Kit.
Panther Fusion® Reconstitution Buffer I.
Hologic CMV Plasmid Control.
Coronavirus (CoV) HKU1 Probe ASR.
Varicella zoster virus (VZV) Probe ASR.
Oil Reagent.
Panther Fusion® AdV/hMPV/RV Controls Kit.
The RNA IC Primers ASR contains forward and reverse primers designed to amplify the RNA target present in the Panther Fusion® Internal Control-S reagent.
Coronavirus (CoV) NL63 Probe ASR.
The DNA IC Probe ASR contains an oligonucleotide designed to detect the DNA target present in the Panther Fusion® Internal Control-S and Panther Fusion® Internal Control-X reagents.
Coronavirus (CoV) 229E Primers ASR.
Panther Fusion® Specimen Lysis Tubes.
Group A Strep (GAS) Probe ASR.
Panther Fusion GI Expanded Bacterial Assay, 96 tests.
Hologic BKV Plasmid Control.
Panther Fusion® Open Access® Diluent Additive.
Panther Fusion® Flu A/B/RSV Controls Kit.
Coronavirus (CoV) OC43 Primers ASR.
Coronavirus (CoV) OC43 Probe ASR.
Panther Fusion® Oil.
Panther Fusion® Open Access® RNA/DNA Enzyme Cartridge, 96 tests.
The Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
Epstein-Barr virus (EBV) Probe ASR.
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay Controls Kit.
Panther Fusion® GBS Controls Kit.
Blood Transport Medium.
Urine Transport Medium.
MAUDE Adverse Events (10)
FDA Classification (67)
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
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Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry
Clinical Chemistry