Field Safety Notices: 13 to 17 November 2023

List of Field Safety Notices from 13 to 17 November 2023.

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

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

bioMérieux: 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

Updates to this page

Published 22 November 2023