Sight OLO CBC Test Kit — Class II medical device recall Z-2173-2024
Ongoing recall by SIGHT DIAGNOSTICS LTD, reported 2024-07-03, distributed nationwide. One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which
| Recall number | Z-2173-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIGHT DIAGNOSTICS LTD, Tel Aviv-Yafo, Israel |
| Recall initiated | 2024-05-13 |
| Classified | 2024-06-21 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IL, SI, TT |
| Reason classes | microbial contamination |
| Lot numbers | 10114 |
| Model numbers | TK1 |
Product
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Reason for recall
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
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-2173-2024. 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.