Field Safety Notices: 28 to 31 December 2020

List of field safety notices (FSNs) from medical device manufacturers from 28 December to 31 December 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: i-STAT CG8+ and EG7+ Cartridges

December 2020

IVDs, extra laboratory testing

MHRA reference: 2020/012/023/701/053

Biosense Webster: nGEN™ RF Generator

23 December 2020

Therapy Tissue Ablation

MHRA reference: 2020/012/024/487/004

DiaMed(BioRad): Refer to attached "FSCA 004-20_product list_v2"

22 December 2020

Refer to attached "FSCA 004-20_product list_v2"

MHRA reference: 2020/012/023/601/002

Molnlycke Health Care: Mölnlycke® Procedure Trays & Single Packed Sterile Trocars

22 December 2020

Surgical devices, non-powered

MHRA reference: 2020/012/022/291/006

QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel

30 December 2020

IVDs, SARS-CoV-2 instrumentation antigen test

MHRA reference: 2020/012/030/487/001

Updates to this page

Published 4 January 2021