Sight OLO CBC Test Kit recall: Contamination
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Why was Sight OLO CBC Test Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: TK1, UDI-DI: B787TK10, Lot Code: 10114
- Product
- Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
- Recalling firm
- SIGHT DIAGNOSTICS LTD
- Quantity
- 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.
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)