Reported Jan 31, 2024 · Ongoing
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- 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.
- Lot codes and dates
- Fusion System Part NumberASY-09600
- UDI CodePending
- Serial Numbers Panther / Fusion
270 of 270 codes
101091003621010008221010910056210100088310109100642101000783101091007521010007861010910111210100065410109101712101000961101091019521010008101010910216210100086610109102202101000500101091034321010007791010910389210100090110109104532101000900101091046121010006751010910470210100064510109105042101000674101091054421010007031010910551210100100110109105712101000837101091064721010008931010910649210100071210109106722101000760101091068621010009791010910690210100077510109106912101000778101091071621010008451010910731210100082710109107322101000831101091073321010008071010910789210100085810109107902101000859
- Amount recalled
- 771 systems (of which 313 are potentially impacted)
Where it was sold
Why it was recalled
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
This product could cause temporary or reversible health problems — stop using it.
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