Z-2517-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- June 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
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
Reason for Recall
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Distribution Pattern
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.
Code Information
Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10