Sight OLO-E1/U1 Software and Operators Manual Software v2 — Class II medical device recall Z-2517-2021
Terminated recall by SIGHT DIAGNOSTICS LTD, reported 2021-09-29, distributed nationwide. Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the
| Recall number | Z-2517-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIGHT DIAGNOSTICS LTD, Tel Aviv-Yafo, Israel |
| Recall initiated | 2021-03-17 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, GB, IL, MX, NL, PT, RU, SG, TH |
| Quantity | 114 units |
| Reason classes | labeling, software |
| Model numbers | OLO-E1, OLO-U1 |
Product
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
Reason for recall
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2517-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.