Drug recall
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1…
FDA recall event 88401 · Class II · SIGHT DIAGNOSTICS LTD
Key facts
| Event ID | 88401 |
|---|---|
| Recall numbers | Z-2517-2021 |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Product type | Devices |
| Products | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software |
| Initiation date | Mar 17, 2021 |
| Report date | Sep 29, 2021 |
| Termination date | Jun 8, 2022 |
| City | Tel Aviv-Yafo |
| Country | Israel |
| FEI number | 3016099075 |
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: