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 | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. |
| Product | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 |
| Quantity | 1690 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy. |
| Initiated | 2021-09-23 |
| Classified | 2021-10-21 |
| Recall number | Z-0162-2022 |
| 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-0162-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88825/
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