Drug recall
NexSys PCS software version 1.4.2 and earlier
FDA recall event 90696 · Class II · Haemonetics Corporation
Key facts
| Event ID | 90696 |
|---|---|
| Recall numbers | B-0161-2023 |
| Recalling firm | Haemonetics Corporation |
| Product type | Biologics |
| Products | NexSys PCS software version 1.4.2 and earlier |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Haemonetics Corporation is recalling distributed devices of NexSys PCS software version 1.4.2 and earlier due to a defect affecting the software when the instrument is configured to run Smart Last… |
| Initiation date | Jul 12, 2022 |
| Report date | Feb 1, 2023 |
| Termination date | Jan 24, 2023 |
| City | Boston |
| State | MA |
| Country | United States |
| FEI number | 1219343 |
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: