Medicines Healthcare Products Regulatory Agency
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
2SAN: Flowflex SARS-CoV-2 Antigen Rapid Test
09 November 2023
MHRA reference: 27570680
Abbott: Assurity, Endurity
October 2023
Dual -chamber impl. Pm
Model: PM2152, PM2162, PM2172, PM2272
MHRA reference: 27580825
Actim: PARTUS TEST
13 November 2023
Insulin-like growth factor binding protein 1 kit
MHRA reference: 27577919
BD: CD11b APC
26 October 2023
Multiple mature lymphocyte cell marker IVD, kit
MHRA reference: 27502820
bioMrieux: BIOFIRE FILMARRAY TORCH
02 November 2023
Thermal cycler nucleic acid amplification analyzer
Model: Shipping Configuration: HTFA-ASY-0001, Part Number: HTFA-ASY-0104
MHRA reference: 27514630
Cepheid: Xpert Xpress CoV-2/Flu/RSV plus
17 October 2023
MHRA reference: 27519669
GE Healthcare: Definium Tempo - Definium Tempo Pro
10 November 2023
Stationary basic diagnostic x-ray system, digital
MHRA reference: 27577197
Getinge: Cardiohelp-I
10 November 2023
Heart-lung bypass System
Model: 701048012; 701072780
MHRA reference: 27566468
Getinge: Cardiohelp-I
26 October 2023
Heart-lung bypass System
Model: 701048012; 701072780; 701052044
MHRA reference: 27509524
Indiana Ophthalmics: AACARB, AACOMER, PUROPTICS
22 November 2023
MHRA reference: 27599055
Kirchner & Wilhelm: SwiSto3
24 October 2023
Iontophoresis systems
MHRA reference: 27560938
Medtronic: Guardian 4 Sensor / HCP letter
November 2023 FA1379
MHRA reference: 27565141
Medtronic: Guardian 4 Sensor / User letter
November 2023 FA1379
MHRA reference: 27565141
mo-vis: Scoot Control
10 November 2023
Model: P015-61 & P015-71
MHRA reference: 27548845
Ortho Clinical Diagnostics: Ortho BioVue System Control (RH/K II) Cassette
23 March 2023
Multiple blood grouping IVD kit, agglutination
MHRA reference: 5134536
Philips: Brilliance CT Big Bore; Philips CT Big Bore
08 November 2023
Full-body CT system
Model: 728242, 728243, 728244
MHRA reference: 27561941
Philips: HeartStart Intrepid Monitor/Defibrillator
10 October 2023
Defibrillators
Model: 867172
MHRA reference: 27478214
Philips: Patient Information Center iX
17 August 2023
Model: 866389, 866390, 867093, 867154
MHRA reference: 27560720
Randox: CALIBRATION SERUM LEVEL 3 (CAL 3)
13 November 2023
Multiple clinical chemistry analyte IVD, calibrato
MHRA reference: 27577830
Randox: Specific Protein Control Levels 1-3
22 November 2022
Multiple clinical chemistry protein IVD, control
MHRA reference: 5193136