Field Safety Notices: 27 to 31 May 2024

List of Field Safety Notices from 27 to 31 May 2024.

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

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer   

24 May 2024 FSN-24024

Model: C11137   

MHRA reference:

Beckman Coulter: Dxl 9000 Access Immunoassay Analyzer

24 May 2024 FSN-24026

Model: C11137 

MHRA reference:

Biocartis: IdyllaTM EGFR Mutation Test  

27 May 2024

Epidermal growth factor receptor (EGFR) gene mutat 

MHRA reference:

bioMérieux: BIOFIRE FILMARRAY TORCH Base  

30 May 2024 

ʹapprmal cycler nucleic acid amplification analyzer 

Model: Shipping Configuration: HTFA-ASY-0001, Part Number: HTFA-ASY-0104 

MHRA reference:

Bolton Surgical: Charnley Multi-Position Cup Holder & Guide  

FSN 24-03-03

Hip prosthesis socket pusher  

MHRA reference:

GE Healthcare: Vivid E95/E90/E80 - Vivid S70/S60  

Ref. # 76200

Ultrasound system, Imaging, Cardiovascular 

MHRA reference:

LumiraDx: Platform Instrument

24 May 2024

In vitro diagnostic medical devices  

Model: V5E

MHRA reference:

Philips: Avalon Ultrasound Transducer   

22 May 2024

Model: 867246

MHRA reference:

Revvity: DELFIA/AutoDELFIA PlGF kit,

28 May 2024

Placental growth factor (PLGF) IVD, kit, fluoresce 

Model: B055-201; B055-301

MHRA reference:  

Smiths Medical: Bivona Neonatal/Pediatric and Adult Tracheostomy

13 June 2024

Tracheostomy tube, non-reinforced, non-customized

MHRA reference:

SURGIRIS: LEDVISION 202 Cardan

22 April 2024

MHRA reference:

Updates to this page

Published 7 June 2024
Last updated 14 June 2024 show all updates
  1. Added 'Smiths Medical: Bivona Neonatal/Pediatric and Adult Tracheostomy - Tracheostomy tube, non-reinforced, non-customized'.

  2. First published.