FDA-Device2022-01-12Class II
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
DiaSorin Molecular LLC
Hazard
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Sold states
US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates.
Affected count
29495 kits
Manufactured in
11331 Valley View St, N/A, Cypress, CA, United States
Products
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0457-2022Don't want to check this manually?
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