Class 2 Device Recall Sight OLO

• Date Initiated by Firm: March 17, 2021
• Create Date: September 22, 2021
• Recall Status: Terminated on June 08, 2022
• Recall Number: Z-2517-2021
• Recall Event ID: 88401
• 510(K)Number: K190898
• Product Classification: Counter, differential cell - Product Code GKZ
• 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
• Code Information: Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
• Recalling Firm/ Manufacturer: SIGHT DIAGNOSTICS LTD; 23, Derekh Menakhem Begin; Tel Aviv-Yafo Israel
• Manufacturer Reason for Recall: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
• FDA Determined 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 possession. Attached to this recall notification is the OLO Operators Manual, rev. 1.14 (U1) and 1.15 (E1). The updated Operator's Manual includes Sights verified reference ranges. Each laboratory should either validate these ranges or establish their own in accordance with their state and regulatory agency guidelines. The software version of the OLO analyzer in your possession will be updated to a new version that includes the above mentioned correction. The update will be performed remotely by Sight's product specialists, who will contact you in the coming month to schedule the update. Please be aware that the software version update requires the analyzer to be connected to the internet. If you are a distributor, please provide a copy of this recall notification and updated Operator s Manual to any customer whom the product was shipped to, or may have been shipped to. If you have been authorised by Sight to translate the Operator s Manual, please make sure you update the Operator s Manual s translation accordingly. You are kindly requested to fill the attached Acknowledgement and Receipt Form, and return it to Sight notifications@sightdx.com within 30 days. If you are required to notify your local authority, please use this notification letter and inform Sight as soon as possible. If you have any questions please contact us at Support@sightdx.com. For full indicati
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GKZ