Simplexa COVID-19 Direct — Class II medical device recall Z-1209-2023
Ongoing recall by DiaSorin Molecular LLC, reported 2023-03-15, distributed nationwide. Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cr
| Recall number | Z-1209-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DiaSorin Molecular LLC, Cypress, CA, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 90,142 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 20816101027020 |
| Lot numbers | MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13967N/MOL4151/15082N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/15061N/MOL4151/13474N |
| Model numbers | MOL4150 |
Product
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1209-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.