Z-2173-2024 Class II Ongoing
FDA device recall Z-2173-2024 was initiated by SIGHT DIAGNOSTICS LTD on May 13, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 7,450 units (2,800 US, 4,650 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2024
- Initiation Date
- May 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,450 units (2,800 US, 4,650 OUS)
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.
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
Code Information
REF: TK1, UDI-DI: B787TK10, Lot Code: 10114
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2173-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026