Simplexa Direct Amplification Disc Kit — Class II medical device recall Z-0457-2022
Ongoing recall by DiaSorin Molecular LLC, reported 2022-01-12, distributed in AZ, CA, CO, CT, DC, FL, GA, HI…. A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Di
| Recall number | Z-0457-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DiaSorin Molecular LLC, Cypress, CA, United States |
| Recall initiated | 2021-11-19 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Distributed | AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AU, CA, CL, IL, IT, KW |
| Quantity | 29,495 kits |
| Reason classes | packaging |
| Lot numbers | 12154N, 12410N, 12411N, 12413N, 12477N, 12602N, 12603N, 12721N, 12889N, 13242N, 13369N, 13370N, 13434N, 13652N, MOL1452 |
Product
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Reason for recall
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
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-0457-2022. 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.