SIGHT DIAGNOSTICS LTD recalls The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image…
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier…
Read the official notice →- Date
- 2022-04-27
- Country
- United States
- Brand
- Sight Diagnostics
- Product
- The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Sight Diagnostics recalls
- 2024-07-03
USSIGHT DIAGNOSTICS LTD recalls Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC…
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…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and…Official notice →- 2022-08-03
- US
SIGHT DIAGNOSTICS LTD recalls Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-27
- US
DNA Genotek Inc. recalls ORAcollect RNA: ORE-100
Evaporation of stabilizing liquid reducing shelf life.
FDA · DeviceDNA Genotek Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis zee floor MN, Model Number 10094142
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a…
- US
St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER3700 programmer Model MER3400 software
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices,…
FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628…
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows.…
- US
Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between…
- US
Huntleigh Healthcare Ltd. recalls HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Faceplate may become detached from the probe body.
FDA · DeviceHuntleigh Healthcare Ltd.US Nationwide distribution in the states of OK, CA, GA, MI, VA.Official notice →