SIMPLEXA COVID-19 Positive Control Pack — Class II medical device recall Z-0162-2022
Ongoing recall by DiaSorin Molecular LLC, reported 2021-10-27, distributed nationwide. Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for
| Recall number | Z-0162-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DiaSorin Molecular LLC, Cypress, CA, United States |
| Recall initiated | 2021-09-23 |
| Classified | 2021-10-21 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IT |
| Quantity | 1,690 kits |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 20816101027051 |
| Lot numbers | 12175N, 12722N, X12122N, X12724N |
| Model numbers | MOL4160 |
Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Reason for recall
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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-0162-2022. 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.