Field Safety Notices: 11 to 15 October 2021
List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 October 2021
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
Last updated 11 August 2022 + show all updates
-
Added updated FSN for Cordis Cashel: Cordis S.M.A.R.T. Flex Vascular Stent System
-
First published.