Class II — DiaSorin Molecular LLC
| Recalling firm | DiaSorin Molecular LLC |
|---|---|
| Registered facility | DiaSorin Molecular LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 4,7878 units |
| Distribution | 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. |
| Initiated | 2023-06-14 |
| Classified | 2023-07-18 |
| Recall number | Z-2153-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DiaSorin Molecular LLC (Z-2153-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92559/
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