Recall Z-2517-2021 ยท GKZ Counter, Differential Cell
SIGHT DIAGNOSTICS LTD
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
| Date | Mar 17, 2021 |
| Status | Terminated |
| Reason | Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software |
| Root cause | Labeling Change Control |
| Action | Sight Diagnosics issued URGENT 2021-03-16 Medical Device Recall Notification on 3/15/21 via email. Letter states reason for recall, health risk and action to take: Corrective and Preventive Actions Taken by the Company: Section 5.7.1 of both OLO-E1 and OLO-U1 Operator s Manuals has been updated to reflect the adult reference ranges verified by Sight. Software version v2.56.1 was updated to software version v2.56.2, which is configured (by default) with the adult reference ranges verified by Sight. Actions to be taken by the customer: Please discard all previous Operator's Manuals in your p |
| Quantity | 114 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190898 | Sight OLO Sight Diagnostics , Ltd., Nov 1, 2019 |