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Field Safety Notices: 1 to 4 September 2020

Medicines Healthcare Products Regulatory Agency

September 7
10:26 2020

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

Abbott: ARCHITECT Galectin?3 Reagent

28 August 2020

IVDs, clinical chemistry

MHRA reference: 2020/009/001/291/004

Advanced Medical Solutions: ACTIVHEAL Hydrogel

2 September 2020

Haemostatic agents

Model: 10014007

MHRA reference: 2020/008/011/601/008

Allmed Medical Products: X-Ray Gauze Swaps

FSN 20-02

Basic dressings, absorbents, swabs, procedure packs

Model: AL002XR, AL004XRA-Bulk, AL005XR, AL006XR, AL007XR, AL008XR, AL017XR, AL021XR, AL026XR

MHRA reference: 2020/009/001/291/002

Bolton Surgical: Bolt Cutter 470mm

200601/20-001

Surgical instruments, non-articulated

Model: Bolt Cutter 470mm - 14-2922-00

MHRA reference: 2020/008/026/487/002

CAPA00852

IVDs, cytopathology & histopathology

Model: AS480; AS100; S3800; S3400

MHRA reference: 2020/009/001/291/005

DragonMobility

6 March 2020

Wheelchairs, powered

Model: SnapDragon

MHRA reference: 2019/012/010/601/007

Fresenius Medical Care: AquaC UNO H

28 August 2020

Dialysis, haemodialysis

Model: F00002272, F00003544, F00003546, F00004565

MHRA reference: 2020/009/001/291/001

FUJIFILM Medical System: Synapse PACS

17 August 2020

Picture Archiving and Communication System (PACS)

MHRA reference: 2020/009/002/487/013

Gentian: Gentian Cystatin C Calibrator

1 September 2020

IVDs, clinical chemistry

MHRA reference: 2020/009/003/291/003

Siemens: Symbia S and Symbia T systems

CAN 001-2020

SPECT-CT system

Model: 8717741, 8717733, 10275007, 10275008, 10275009, 10275010

MHRA reference: 2020/008/027/601/003

Sysmex: Sysmex Automated Blood Coagulation Analyzer

August 2020

Coagulation

Model: CN-6000, CN-3000, CS-5100, CS-2000i, CS-2100i, CS-2400, CS-2500, CS-1600, CS-1300, CA-510, CA-520, CA-530, CA-540, CA-550, CA-560, CA-620, CA-650, CA-660, CA-1500, CA-7000, CA-8000

MHRA reference: 2020/009/002/487/017

Ventana Medical Systems (Roche): Benchmark Ultra Stainer Module

18 August 2020

IVDs, cytopathology & histopathology

Model: 05342716001

MHRA reference: 2020/009/001/291/003

Published 7 September 2020

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