Field Safety Notices: 10 to 14 October 2022

List of Field Safety Notices (FSNs) from 10 to 14 October 2022

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: Cholestech LDX Test Cassettes

29 July 2022

IVDs, Extra Laboratory Testing

MHRA reference: 2022/008/003/601/500

Acumed: Acu-Loc® 2 CORE Full Trial VDR Platter

19 September 2022

Joint Prosthesis, Misc

Model: 80-1997

MHRA reference: 2022/009/019/601/500

B Braun: GELITA-TAMPON (Several, see Point 8)

10 October 2022

Haemostatic Agents

Model: 2070014; 2070103; 2070154; 2070600; 2070707

MHRA reference: 2022/010/010/601/004

Boston Scientific

03 October 2022

Implants, Active, Cardiac Subcutaneous system

Model: A209 - A219

MHRA reference: 2022/010/013/596/001

Boston Scientific: ORISE™ Gel Submucosal Lifting Agent

10 October 2022

Endoscopes, Flexible

MHRA reference: 2022/010/011/596/002

Gelita Medical: Tuft-it

08 September 2022

Haemostatic Agents

MHRA reference: 2022/009/013/601/501

LeMaitre: Syntel Silicone Over the Wire Embolectomy Catheter

30 September 2022

Vascular Cannula And Catheters

MHRA reference: 2022/009/001/601/004

MicroVention Terumo: WDC-2: Web Detachment Controller

20 September 2022

Vascular plug / occluders

Model: WDC-2

MHRA reference: 2022/009/020/601/002

One lambda: LinkSēq™ HLA-ABCDRDQDP+ 384 Typing Kit

06 October 2022

IVDs, Immunology

MHRA reference: 2022/010/007/611/002

Ortho Clinical Diagnostics: VITROS HIV Combo Reagent Pack 6842779 and 6842780

05 September 2022

IVDs, Viral Microbiology

MHRA reference: 2022/009/006/601/502

Randox: Serology I Positive Control

02 August 2022

IVDs, Clinical Chemistry

Model: SR10352

MHRA reference: 2022/010/010/601/502

Siemens Healthineers: Lithium_2 (LITH_2) reagents Lithium (Li) reagents

September 2022

IVDs, Clinical Chemistry

Model: Atellica CH Lithium_2 (LITH_2) 11532401 Atellica CH Lithium (Li) 11097535

MHRA reference: 2022/009/022/601/500

Updates to this page

Published 17 October 2022