Sight OLO Test Kit
Brand(s)
Last updated
Summary
Product
Sight OLO Test Kit
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Sight OLO Test Kit |
10114 |
TK1 |
Issue
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.
Recall Start Date: May 15, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Pathology
Companies
S.D. Sight Diagnostics Ltd.
23 Menachem Begin Rd., Tel Aviv, Israel, 6618356
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-75625
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