Sight Diagnostics Ltd FDA Recalls

4 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Class IIMay 13, 2024One Test Kit lot (TK1-10114) shows a positive bias in the pl	One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which	Class IIDevices	May 13, 2024
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1Class IIJun 14, 2022The default reference ranges for MCH, MCHC, and RDW for age	The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly d	Class IIDevices	Jun 14, 2022
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algoClass IIJan 20, 2022In instances where custom reference ranges were configured o	In instances where custom reference ranges were configured on the device post installation, a possibility to	Class IIDevices	Jan 20, 2022
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.Class IIMar 17, 2021Discrepancy in labeling between the adult CBC reference rang	Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the	Class IIDevices	Mar 17, 2021