SIGHT DIAGNOSTICS LTD recalls Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, re…
- Recall date
- March 17, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2517-2021
- FDA classification
- Class II
- Brand / firm
- SIGHT DIAGNOSTICS LTD
- Sold / distributed
- 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.
Why it was recalled
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever SIGHT DIAGNOSTICS LTD has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: SIGHT DIAGNOSTICS LTD