SIGHT DIAGNOSTICS LTD: Device Recall
Recall #Z-2173-2024 · 05/13/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2173-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SIGHT DIAGNOSTICS LTD
- Status
- Ongoing
- Date Initiated
- 05/13/2024
- Location
- Tel Aviv-Yafo, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,450 units (2,800 US, 4,650 OUS)
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.
Product Description
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.