DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo

Recalled July 26, 2023 · FDA recall Z-2153-2023 · DiaSorin Molecular

Hazard

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. · FDA Class II

Units

4,7878 units

Sold at

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.

Description

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

Product

Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

Manufacturer(s)

DiaSorin Molecular LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →