SIGHT DIAGNOSTICS LTD Recall 88401
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
SIGHT DIAGNOSTICS LTD Recall 88401 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2517-2021 |
| Event ID | 88401 |
| Event 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 |
| Product Type | Devices |
| 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. |
| Quantity | 114 units |
| Recall Reason | Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software |
| Device Classification | 20210929 |
| Device Code Info | Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10 |
| Center Classification Date | 20210922 |
| Recall Initiation Date | 20210317 |
| Recalling Firm | SIGHT DIAGNOSTICS LTD |
| Initial Notification | |
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