SIGHT DIAGNOSTICS LTD 2022-08-03 Health serious FDA
Health · FDA · Recall #FDA-Z-1469-2022
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Recall
Issued August 3, 2022 · SIGHT DIAGNOSTICS LTD
In August 2022, SIGHT DIAGNOSTICS LTD recalled the Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
What you should do
- 1 Stop using Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SIGHT DIAGNOSTICS LTD to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SIGHT DIAGNOSTICS LTD
- Category
- Health
- Recall date
- August 3, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentuc
- Recall number
- FDA-Z-1469-2022
- Made in
- Israel
- Issuing agency
- FDA
In context
- SIGHT DIAGNOSTICS LTD has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.