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Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fu
Recalled March 23, 2022 · FDA recall Z-0750-2022 · Hologic
Hazard
Failed stability specifications for reagent kits that may result in false negative test results. · FDA Class II
Units
264 kits
Sold at
Worldwide distribution - US Nationwide distribution in the states of AR, CA, CT, FL, GA, ID, IL, IN, MA, MD, ME, MI, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV, District of Columbia and the countries of Canada, Australia, Belgium, Netherlands, China, Italy, Germany, Sweden.
Description
Failed stability specifications for reagent kits that may result in false negative test results.
Product
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →