Sight Diagnostics recalls
3 official recalls and safety alerts involving Sight Diagnostics since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sight Diagnostics or the relevant agency.
- 2024-07-03
USSIGHT DIAGNOSTICS LTD recalls Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC…
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…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and…Official notice →- 2022-08-03
- US
SIGHT DIAGNOSTICS LTD recalls Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice → - 2022-04-27
- US
SIGHT DIAGNOSTICS LTD recalls The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image…
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA,…Official notice →