FDA-Device2023-03-15Class II
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
DiaSorin Molecular LLC
Hazard
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Sold states
US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.
Affected count
90142
Manufactured in
11331 Valley View St, Cypress, CA, United States
Products
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1209-2023Don't want to check this manually?
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