FDA recall Z-2517-2021

Product

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

Reason for recall

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-03-17

Report date

2021-09-29

Termination date

2022-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tel Aviv-Yafo, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2517-2021