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