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 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
bioMérieux: 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
Last updated 14 June 2024 + show all updates
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Added 'Smiths Medical: Bivona Neonatal/Pediatric and Adult Tracheostomy - Tracheostomy tube, non-reinforced, non-customized'.
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First published.