Sight OLO — Class II medical device recall Z-1469-2022
Ongoing recall by SIGHT DIAGNOSTICS LTD, reported 2022-08-03, distributed nationwide. The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly d
| Recall number | Z-1469-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIGHT DIAGNOSTICS LTD, Tel Aviv-Yafo, Israel |
| Recall initiated | 2022-06-14 |
| Classified | 2022-07-27 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BZ, CA, CW, DE, ES, FI, GB, GR, HK, ID, IE, IL, IN, IT, MX, PT, QA, SE, SI, TH, ZA |
| Reason classes | software |
| Serial numbers | Q100, Q121, Q127, Q138, Q145, Q159, Q167, Q175, Q176, Q191, Q209, Q212, Q216, Q218, Q221, Q234, Q236, Q243, Q245, Q246, Q256, Q261, Q262, Q263, Q264 and 346 more |
| Model numbers | OLO-U1 |
Product
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Reason for recall
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
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-1469-2022. 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.