Simplexa Direct Amplification Disc Kit — Class II medical device recall Z-2153-2023
Ongoing recall by DiaSorin Molecular LLC, reported 2023-07-26, distributed nationwide. There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid f
| Recall number | Z-2153-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DiaSorin Molecular LLC, Cypress, CA, United States |
| Recall initiated | 2023-06-14 |
| Classified | 2023-07-18 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, IL, IT |
| Quantity | 4,787 |
| Reason classes | device malfunction |
| Lot numbers | MOL1452, P15886N, P16794N, P16795N, P16796N, P16883N, P16885N, P17022N, P17023N, P17044N, P17046N, P17047N, P17052N, P17056N, P17057N, P17176N, P17177N, P17178N, P17294N, P17295N, P17296N, P17301N, P17302N, P17303N, P17304N, P17305N, P17306N, P17351N, P17352N, P17353N, P17354N, P17359N, P17361N, P17362N, P17614N, P17625N, P17650N, P17652N, P17653N, P17654N and 3 more |
| Model numbers | MOL1452, MOL1455 |
Product
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Reason for recall
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
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-2153-2023. 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.