FDAFDA · Food and drugs·Recall number Z-2173-2024
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Published July 3, 2024 · Recall initiated: May 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SIGHT DIAGNOSTICS LTD
- Distributor
- Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
- Lot
- REF: TK1, UDI-DI: B787TK10, Lot Code: 10114
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.