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

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View . FSNs before this date are on the

Abbott: Cholestech LDX Test Cassettes

29 July 2022

IVDs, Extra Laboratory Testing

MHRA reference:

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

19 September 2022

Joint Prosthesis, Misc

Model: 80-1997

MHRA reference:

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

10 October 2022

Haemostatic Agents

Model: 2070014; 2070103; 2070154; 2070600; 2070707

MHRA reference:

Boston Scientific

03 October 2022

Implants, Active, Cardiac Subcutaneous system

Model: A209 - A219

MHRA reference:

Boston Scientific: ORISE鈩� Gel Submucosal Lifting Agent

10 October 2022

Endoscopes, Flexible

MHRA reference:

Gelita Medical: Tuft-it

08 September 2022

Haemostatic Agents

MHRA reference:

LeMaitre: Syntel Silicone Over the Wire Embolectomy Catheter

30 September 2022

Vascular Cannula And Catheters

MHRA reference:

MicroVention Terumo: WDC-2: Web Detachment Controller

20 September 2022

Vascular plug / occluders

Model: WDC-2

MHRA reference:

One lambda: LinkS膿q鈩� HLA-ABCDRDQDP+ 384 Typing Kit

06 October 2022

IVDs, Immunology

MHRA reference:

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

05 September 2022

IVDs, Viral Microbiology

MHRA reference:

Randox: Serology I Positive Control

02 August 2022

IVDs, Clinical Chemistry

Model: SR10352

MHRA reference:

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:

Updates to this page

Published 17 October 2022