7 results
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7ms
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Sources: EU EUDAMED, US FDA
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·July 3, 2024
Alinity hq Analyzer, REF: 09P68-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 28, 2024
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
FDA Enforcement
Class II
·Ongoing·SIGHT DIAGNOSTICS LTD·April 27, 2022
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019
Bodor's I series laser cutting machine.
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·July 30, 2025
Bodor P and C series laser cutting machines
FDA Enforcement
Class II
·Ongoing·Jinan Bodor Cnc Machine Co Ltd·January 29, 2025