Sight Olo-E1 & Sight Olo-U1 recall in Canada: Performance issue
In plain language
This recall involves Sight Olo-E1 and Sight Olo-U1 medical devices sold in Canada. They are being recalled because of a performance issue with incorrect reference ranges for MCH, MCHC, and RDW in child demographics. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer, S.D. Sight Diagnostics Ltd., if you require additional information.
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Affected products
Sight Olo-E1
Model: OLO-E1
Lot: version 2.63.1.1, version 2.63.1, version 2.63
Sight Olo-U1
Model: OLO-U1
Lot: version 2.63.1.1, version 2.63.1, version 2.63
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: version 2.63.1.1, version 2.63.1, version 2.63
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: OLO-E1, OLO-U1
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Contact the manufacturer, S.D. Sight Diagnostics Ltd., if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on July 11, 2022.
Is the S.D. Sight Diagnostics Ltd. brand affected by this recall?
Yes, S.D. Sight Diagnostics Ltd. products are affected by this recall. This recall involves Sight Olo-E1 and Sight Olo-U1 medical devices sold in Canada. They are being recalled because of a performance issue with incorrect reference ranges for MCH, MCHC, and RDW in child demographics. Healthcare professionals should contact the manufacturer for more information.