Recall Z-2173-2024— SIGHT DIAGNOSTICS LTD
Class II · Ongoing
Class II FDA medical device recall by SIGHT DIAGNOSTICS LTD, initiated 2024-05-13. It names 2 FDA 510(k) clearances: K211840, K190898. 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.. Reason: 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..
- Recalling firm
- SIGHT DIAGNOSTICS LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-13
- Firm location
- Tel Aviv-Yafo, Israel
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.