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 proce

Hazard

Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.

Details from the source

Reason for recall: Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. 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, N Quantity: 771 systems (of which 313 are potentially impacted) Lot/code info: 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 2090

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.