Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Reported: July 3, 2024 Initiated: May 13, 2024 #Z-2173-2024
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.
Details
- Recalling Firm
- SIGHT DIAGNOSTICS LTD
- Units Affected
- 7,450 units (2,800 US, 4,650 OUS)
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
- Location
- Tel Aviv-Yafo
Frequently Asked Questions
What product was recalled? ▼
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.. Recalled by SIGHT DIAGNOSTICS LTD. Units affected: 7,450 units (2,800 US, 4,650 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2173-2024.
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