Health product recall

Sight Olo-E1 & Sight Olo-U1

Last updated

Summary

Product
Sight Olo-E1 & Sight Olo-U1
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Sight Olo-E1

version 2.63.1.1
version 2.63.1
version 2.63

OLO-E1

Sight Olo-U1

version 2.63.1.1
version 2.63.1
version 2.63

OLO-U1

Issue

The reference ranges of MCH, MCHC and RDW are mixed in the child (2-<12 years old) demographics. if the user has not overridden them, they will be incorrectly displayed.

Recall start date: June 14, 2022

Additional information

Details
Original published date: 2022-07-13
Alert / recall type
Health product recall
Category
Health product - Medical device - Haematology
Companies

S.D. Sight Diagnostics Ltd.

23 Menachem Begin Rd., Tel Aviv, Israel, 6618356

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64349