Drug recall
PCS2 software versions K.2, K.1, K, J, H non-express
FDA recall event 90697 · Class II · Haemonetics Corporation
Key facts
| Event ID | 90697 |
|---|---|
| Recall numbers | B-0174-2023 |
| Recalling firm | Haemonetics Corporation |
| Product type | Biologics |
| Products | PCS2 software versions K.2, K.1, K, J, H non-express |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Haemonetics Corporation has identified a defect affecting the distributed PCS2 (110V) software versions K.2, K.1, K, J and H (non-Express), when the instrument is configured to run Smart Last Cycle. |
| Initiation date | Jul 12, 2022 |
| Report date | Feb 8, 2023 |
| Termination date | Jan 27, 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: