Reported Jul 3, 2024 · Ongoing
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the…
Sight Diagnostics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIGHT DIAGNOSTICS LTD · 23, Derekh Menakhem Begin · Tel Aviv-Yafo · N/A
Is this the product you have?
- Sight OLO CBC Test Kit
- Model/Catalog NumberTK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer
- Lot codes and dates
- REFTK1
- UDI-DIB787TK10
- Lot Code10114
- Amount recalled
- 7,450 units (2,800 US, 4,650 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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