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 | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes. |
| Product | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 |
| Quantity | 90142 |
| Distribution | US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA. |
| Initiated | 2023-01-30 |
| Classified | 2023-03-03 |
| Recall number | Z-1209-2023 |
| 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-1209-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91504/
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