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  Â
24 May 2024 FSN-24024
Model: C11137Â Â Â
MHRA reference: ÌýÌýÌýÌý
Beckman Coulter: Dxl 9000 Access Immunoassay Analyzer
24 May 2024 FSN-24026
Model: C11137Â
MHRA reference: ÌýÌýÌýÌý
Biocartis: IdyllaTM EGFR Mutation Test Â
27 May 2024
Epidermal growth factor receptor (EGFR) gene mutatÂ
MHRA reference: ÌýÌýÌýÌý
bioMérieux: BIOFIRE FILMARRAY TORCH Base Â
30 May 2024Â
Thermal cycler nucleic acid amplification analyzerÂ
Model: Shipping Configuration: HTFA-ASY-0001, Part Number: HTFA-ASY-0104Â
MHRA reference: ÌýÌýÌýÌý
Bolton Surgical: Charnley Multi-Position Cup Holder & Guide Â
FSN 24-03-03
Hip prosthesis socket pusher Â
MHRA reference: ÌýÌýÌýÌý
GE Healthcare: Vivid E95/E90/E80 - Vivid S70/S60Â Â
Ref. # 76200
Ultrasound system, Imaging, CardiovascularÂ
MHRA reference: ÌýÌýÌýÌý
LumiraDx: Platform Instrument
24 May 2024
In vitro diagnostic medical devices Â
Model: V5E
MHRA reference: ÌýÌýÌýÌý
Philips: Avalon Ultrasound Transducer  Â
22 May 2024
Model: 867246
MHRA reference: ÌýÌýÌýÌý
Revvity: DELFIA/AutoDELFIA PlGF kit,
28 May 2024
Placental growth factor (PLGF) IVD, kit, fluoresceÂ
Model: B055-201; B055-301ÌýÌýÌýÌý
MHRA reference: ÌýÌýÌýÌýÂ
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: