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…
Read the official notice →- Date
- 2022-08-03
- Country
- United States
- Brand
- Sight Diagnostics
- Product
- Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of Alabama,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
US
SIGHT 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 →- 2022-04-27
US
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…
FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-08-03
US
Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental…
FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide and the countries of Australia, Chile,…Official notice →US
Stryker Instruments recalls Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical…
FDA · DeviceStryker InstrumentsWorldwide distribution - US Nationwide distribution in the states of Arizona,…Official notice →US
MEDLINE INDUSTRIES, LP - SPT recalls Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…
Kits contain leaking bottles of isopropyl alcohol
US
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
FDA · DeviceParagon 28, Inc.U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.Official notice →US
Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number:…
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
FDA · DeviceCovidien LlcAZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom…Official notice →US
GE Healthcare, LLC recalls Centricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of CO, NV,…Official notice →