Field Safety Notices: 15 to 19 May 2023

List of Field Safety Notices (FSNs) from 15 to 19 May 2023

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

Bridge to Life: Belzer UW Cold Storage Solution & Belzer MPS

May 2023

MHRA reference: 5239376

Draeger: Oxylog 3000 plus

May 2023

Ventilators, Transport

MHRA reference: 5235382

Medline: Sterile Ultrasound Gel

12 May 2023

MHRA reference: 5233673

Ortho Clinical Diagnostics: VITROS Chemistry Products HbA1c Reagent

CL2023-096a_EU

Glycated Hb(HbA1c)IVD kit,nephlometry/turbidimetry

MHRA reference: 5236910

RAL Diagnostics: Buffer solution for automated systems

06 April 2023

Model: 75050SX5000; 75050SX7010; 75040SX5000

MHRA reference: 5196884

Roche: Elecsys® Troponin T hs / Elecsys Troponin T hs STAT: discrepant elevated results with certain plasma EDTA primary tubes

January 2023

MHRA reference: 5205171

SCHILLER: SCHILLER FRED PA-1 DEFIBRILLATOR

April 2023

Model: FRED PA-1

MHRA reference: 5236202

Siemens Healthineers: Aptio Automation Storage and Retrieval Module

May 2023

Specimen processing instrument IVD, automated <

MHRA reference: 5239339

Terumo Aortic: TREO Abdominal Stent-Graft System

12 May 2023

Abdominal aorta endovascular stent-graft

MHRA reference: 5216917

ThermoFisher Scientific: EliA GBM Well

QA2023-05 May 2023

Glomerular basement membrane antibody IVD, kit

Model: 14-5514-01

MHRA reference: 5235366

Updates to this page

Published 23 May 2023