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聽聽聽

24 May 2024 FSN-24024

Model: C11137聽聽聽

MHRA reference: 听听听听

Beckman Coulter: Dxl 9000 Access Immunoassay Analyzer

24 May 2024 FSN-24026

Model: C11137聽

MHRA reference: 听听听听

Biocartis: IdyllaTM EGFR Mutation Test聽聽

27 May 2024

Epidermal growth factor receptor (EGFR) gene mutat聽

MHRA reference: 听听听听

bioM茅rieux: BIOFIRE FILMARRAY TORCH Base聽聽

30 May 2024聽

Thermal cycler nucleic acid amplification analyzer聽

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

MHRA reference: 听听听听

Bolton Surgical: Charnley Multi-Position Cup Holder & Guide聽聽

FSN 24-03-03

Hip prosthesis socket pusher聽聽

MHRA reference: 听听听听

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

Ref. # 76200

Ultrasound system, Imaging, Cardiovascular聽

MHRA reference: 听听听听

LumiraDx: Platform Instrument

24 May 2024

In vitro diagnostic medical devices聽聽

Model: V5E

MHRA reference: 听听听听

Philips: Avalon Ultrasound Transducer聽聽聽

22 May 2024

Model: 867246

MHRA reference: 听听听听

Revvity: DELFIA/AutoDELFIA PlGF kit,

28 May 2024

Placental growth factor (PLGF) IVD, kit, fluoresce聽

Model: B055-201; B055-301听听听听

MHRA reference: 听听听听聽

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.