Sight Olo-E1 & Sight Olo-U1
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
Get notified
Receive notifications for new and updated recalls and alerts by category.