Class 2 Device Recall Sight OLO

• Date Initiated by Firm: May 13, 2024
• Date Posted: June 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2173-2024
• Recall Event ID: 94678
• 510(K)Number: K190898 K211840
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
• Code Information: REF: TK1, UDI-DI: B787TK10, Lot Code: 10114
• Recalling Firm/ Manufacturer: SIGHT DIAGNOSTICS LTD; 23, Derekh Menakhem Begin; Tel Aviv-Yafo Israel
• For Additional Information Contact: Customer Support; 1-833-7444839 Ext. 3
• Manufacturer Reason for Recall: One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
• FDA Determined Cause: Process control
• Action: On May 15, 2024, URGENT Medical Device Recall letters were sent to customers. Following identification of the affected lot units, please take the following action: 1. Please discontinue use and quarantine any product from Lot 10114. 2. Return any unused units of test kit Lot 10114 to the company or discard them immediately according to standard practice. NOTE: For return of unused test kits please indicate so in the acknowledgement and receipt form and Customer Support will contact you with further instructions. 3. Review previously obtained test results conducted with the affected lot and identify populations at higher risk. Retest if necessary. NOTE: If you require assistance in identifying samples tested using the affected lot please indicate so in the acknowledgment and receipt form and we will be happy to provide you with any necessary information. 4. If you are a distributor, please share this notification with any customer to whom the product was shipped, or may have been shipped. 5. You are kindly requested to fill out the attached Acknowledgement and Receipt Form and return it to Sight as soon as possible, and in any case no later than 30 days from the date of this notification, via email, to notifications@sightdx.com. Please provide the form even if you no longer have any product in inventory so that we can verify that all affected product has been removed. 6. If you are required to notify your local authority please use this notification and notify Sight as soon as possible. We appreciate your time and apologize for any inconvenience this may have caused. Please do not hesitate to reach out with any questions or feedback to Customer Support via the following channels: US Customers OLOsupport@sightdx.com Callback service (voicemail) +1-833-SIGHTDX (7444839 ext. 3) Text +1 617 4105226 Partners (Distributors) support@sightdx.com Callback service (voicemail) +44 0203 093 0772 (ext. 2) Text +44 7449 063724 Customer Support is available Mon-Fri EST- 2:00AM-7:00
• Quantity in Commerce: 7,450 units (2,800 US, 4,650 OUS)
• Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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