Drug recall
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA)…
FDA recall event 93388 · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Event ID | 93388 |
|---|---|
| Recall numbers | Z-0601-2024 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Product type | Devices |
| Products | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run… |
| Initiation date | Oct 19, 2023 |
| Report date | Dec 27, 2023 |
| City | Norwood |
| State | MA |
| Country | United States |
| FEI number | 3002637618 |
At a glance
- 1–9 Products in this recall
- None 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: