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 . FSNs before this date are on the
Bridge to Life: Belzer UW Cold Storage Solution & Belzer MPS
May 2023
MHRA reference:
Draeger: Oxylog 3000 plus
May 2023
Ventilators, Transport
MHRA reference:
Medline: Sterile Ultrasound Gel
12 May 2023
MHRA reference:
Ortho Clinical Diagnostics: VITROS Chemistry Products HbA1c Reagent
CL2023-096a_EU
Glycated Hb(HbA1c)IVD kit,nephlometry/turbidimetry
MHRA reference:
RAL Diagnostics: Buffer solution for automated systems
06 April 2023
Model: 75050SX5000; 75050SX7010; 75040SX5000
MHRA reference:
Roche: Elecsys庐 Troponin T hs / Elecsys Troponin T hs STAT: discrepant elevated results with certain plasma EDTA primary tubes
January 2023
MHRA reference:
SCHILLER: SCHILLER FRED PA-1 DEFIBRILLATOR
April 2023
Model: FRED PA-1
MHRA reference:
Siemens Healthineers: Aptio Automation Storage and Retrieval Module
May 2023
Specimen processing instrument IVD, automated <
MHRA reference:
Terumo Aortic: TREO Abdominal Stent-Graft System
12 May 2023
Abdominal aorta endovascular stent-graft
MHRA reference:
ThermoFisher Scientific: EliA GBM Well
QA2023-05 May 2023
Glomerular basement membrane antibody IVD, kit
Model: 14-5514-01
MHRA reference: