Drug recall
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
FDA recall event 89098 · Class II · DiaSorin Molecular LLC
Key facts
| Event ID | 89098 |
|---|---|
| Recall numbers | Z-0457-2022 |
| Recalling firm | DiaSorin Molecular LLC |
| Product type | Devices |
| Products | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 19, 2021 |
| Report date | Jan 12, 2022 |
| City | Cypress |
| State | CA |
| Country | United States |
| FEI number | 2023365 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: