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…
Read the official notice →- Date
- 2024-07-03
- Country
- United States
- Brand
- Sight Diagnostics
- Product
- Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-03
USSIGHT 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 →- 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
- 2024-07-03
- US
Dental EZ Group Star Dental Division recalls Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival…
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- US
Maquet Cardiovascular, LLC recalls The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2.…
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia Brazil,…Official notice → - US
Roche Diabetes Care, Inc. recalls Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as…
- US
GE Healthcare Finland Oy recalls CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f)…
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the…
- US
Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration…
Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment
FDA · DeviceIntegra LifeSciences Corp.Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia…Official notice → - US
Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model…
Potential for coils to heat up and harm patients (burn).
FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan,…Official notice →