Recall record at a glance
| Official record | Z-2517-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Report date | Sep 29, 2021 |
| Recall initiation date | Mar 17, 2021 |
| Quantity | 114 units |
| Location | Tel Aviv-Yafo, Israel |
Official product description
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Why the product was recalled
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Distribution information
Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico, NETHERLANDS, Portugal, Russia, Singapore, Thailand.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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