SIGHT DIAGNOSTICS LTD: Medical Device Recall in 2024 - (Recall #: Z-2173-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 13, 2024

Date Posted: July 3, 2024

Recall Number: Z-2173-2024

Event ID: 94678

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.

Status: Ongoing

Product Quantity: 7,450 units (2,800 US, 4,650 OUS)

Code Information:

REF: TK1, UDI-DI: B787TK10, Lot Code: 10114

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.

Voluntary or Mandated:

Voluntary: Firm initiated