Recall Z-2173-2024 ยท GKZ Counter, Differential Cell
SIGHT DIAGNOSTICS LTD
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
| Date | Jun 21, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 ide |
| Quantity | 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. |
| FDA record | Open on fda.gov |