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Field Safety Notices: 11 to 15 October 2021

Medicines Healthcare Products Regulatory Agency

August 11
13:48 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: Alinity m SARS-CoV-2 AMP Kit & Alinity m Resp-4-Plex Amp Kit

02 September 2021

IVDs, SARS-CoV-2 PCR test

MHRA reference: 2021/009/006/487/005

Argon Medical: SuperCore Semi-Automatic Biopsy Instrument

04 October 2021

Surgical instruments, minimal access

Model: 701114090, 701114150, 701116090, 701118090, 701118150, 701118200, 701120090, 701120150, 701120200, 701214090, 701214150, 701216090, 701216150, 701218090, 701218150, 701218200, 701220090, 701220150, and 701220200

MHRA reference: 2021/010/006/701/027

Atrium Medical: Atrium Pneumostat Chest Drain Valve

07 September 2021

Chest drains and accessories

Model: 16100

MHRA reference: 2021/009/006/487/003

Baxter Healthcare: 955558 PrisMax, V2

12 October 2021

Dialysis, haemofilters

MHRA reference: 2021/010/008/579/006

Beckman Coulter: Stem-Kit Reagents 50 Tests

01 October 2021

IVDs, clinical chemistry

MHRA reference: 2021/010/006/601/503

BIOMERIEUX: API 50 CH

11 October 2021

IVDs, bacteriology

MHRA reference: 2021/010/011/579/010

Cook Medical: Transseptal Needle and Transseptal Needle with Catheter

08 October 2021

Vascular cannula/catheter accessories

Model: TSNC-18-71.0, TSNC-19-56.0 and TSN-17-75.0-ENDRYS

MHRA reference: 2021/010/011/579/012

Cordis Cashel: Cordis S.M.A.R.T. Flex Vascular Stent System

01 October 2021

Implants, non active, peripheral vascular stents

MHRA reference: 2021/010/008/701/047

The above FSN has been updated due the manufacturer expanding the scope of devices that were originally cited in their October 2021 FSN.

Updated FSN: 2021/010/008/701/047

Elekta: Oncentra Brachy

October 2021

Radiotherapy planning and verification systems

MHRA reference: 2021/010/014/579/015

Exactech: Knee and Ankle UHMWPE inserts

15 September 2021

Joint prosthesis, knee

MHRA reference: 2021/009/006/701/047

GE Healthcare: Lullaby Resus (Prime and Plus)

32081

Breathing system components

MHRA reference: 2021/010/012/579/009

Medtronic: MiniMed 640G and 670G Insulin Pump

October 2021/FA896 phase II

Infusion systems

Model: MMT-1711, MMT-1712, MMT-1751, MMT-1752, MMT-1761, MMT-1762, MMT-1781, MMT-1782

MHRA reference: 2019/011/021/291/008

Medtronic: MiniMed remote controller

October 2021/FA830 Phase II

Infusion systems

Model: MMT-500, MMT-503

MHRA reference: 2021/010/011/579/013

Primerdesign: Genesig Real-Time PCR Coronavirus COVID-19 CE IVD kit

28 June 2021

IVDs, SARS-CoV-2 PCR test

Model: Z-Path-COVID-19-CE

MHRA reference: 2021/010/005/601/002

Radiometer Medical: D513 Disposable Waste Container

FAN 915-417

IVDs, extra laboratory testing

MHRA reference: 2021/010/008/579/007

RT Diagnostics: COVID-19 PCR Sampling Kits

14 September 2021

IVDs, SARS-CoV-2 PCR test

MHRA reference: 2021/009/027/601/505

Siemens Healthcare: Syngo Application Software

September 2021/AX058/21/S

X Ray, general

MHRA reference: 2021/009/023/601/502

Siemens Healthcare: Sensis / Sensis Vibe

September 2021/AX066/21/S

Electrophysiology measurement

MHRA reference: 2021/010/005/601/500

Spacelabs Healthcare: Eclipse Pro Ambulatory Holter Recorder

21 September 2021

Electrophysiology measurement

Model: 98700

MHRA reference: 2021/009/029/701/061

Thermo Fisher: ThermoScientific Oxoid Egg Yolk Emulsion

06 October 2021

IVDs, bacteriology

Model: SR0047C

MHRA reference: 2021/010/006/601/501

Published 19 October 2021
Last updated 11 August 2022 +show all updates
  1. Added updated FSN for Cordis Cashel: Cordis S.M.A.R.T. Flex Vascular Stent System

  2. First published.

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