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Field Safety Notices: 27 to 31 May 2024

Medicines Healthcare Products Regulatory Agency

June 14
11:04 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 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

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

24 May 2024 FSN-24024

Model: C11137

MHRA reference: 30694403

Beckman Coulter: Dxl 9000 Access Immunoassay Analyzer

24 May 2024 FSN-24026

Model: C11137

MHRA reference: 30696320

Biocartis: IdyllaTM EGFR Mutation Test

27 May 2024

Epidermal growth factor receptor (EGFR) gene mutat

MHRA reference: 30712955

bioMrieux: BIOFIRE FILMARRAY TORCH Base

30 May 2024

Thermal cycler nucleic acid amplification analyzer

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

MHRA reference: 30681174

Bolton Surgical: Charnley Multi-Position Cup Holder & Guide

FSN 24-03-03

Hip prosthesis socket pusher

MHRA reference: 30712852

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

Ref. # 76200

Ultrasound system, Imaging, Cardiovascular

MHRA reference: 30673223

LumiraDx: Platform Instrument

24 May 2024

In vitro diagnostic medical devices

Model: V5E

MHRA reference: 30676013

Philips: Avalon Ultrasound Transducer

22 May 2024

Model: 867246

MHRA reference: 30701574

Revvity: DELFIA/AutoDELFIA PlGF kit,

28 May 2024

Placental growth factor (PLGF) IVD, kit, fluoresce

Model: B055-201; B055-301

MHRA reference: 30673017

Smiths Medical: Bivona Neonatal/Pediatric and Adult Tracheostomy

13 June 2024

Tracheostomy tube, non-reinforced, non-customized

MHRA reference: 30826025

SURGIRIS: LEDVISION 202 Cardan

22 April 2024

MHRA reference: 30678776

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.

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