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 | 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. |
| Product | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 |
| Quantity | 29495 kits |
| Distribution | 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. |
| Initiated | 2021-11-19 |
| Classified | 2022-01-05 |
| Recall number | Z-0457-2022 |
| 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-0457-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89098/
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