Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sight OLO CBC Test Kit Recalled by SIGHT DIAGNOSTICS LTD Due to One Test Kit lot (TK1-10114) shows a positive...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SIGHT DIAGNOSTICS LTD directly.
Affected Products
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Quantity: 7,450 units (2,800 US, 4,650 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SIGHT DIAGNOSTICS LTD
SIGHT DIAGNOSTICS LTD has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report