Field Safety Notice - 23 to 27 July 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 July 2018

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 FSN

View the latest FSNs

Abbott: ARCHITECT Creatine Kinase

18 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/020/291/004

Abbott: ARCHITECT EBV VCA IgM

24 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/026/228/002

Cepheid: Xpert C.Difficile BT

04 July 2018

IVDs, bacteriology

MHRA reference: 2018/007/023/701/008

Depuy Synthes: P.F.C.™ SIGMA® Revision Knee System Distal Augment

20 July 2018

Joint prosthesis, knee

Model: 960830

MHRA reference: 2018/007/013/291/003

DiaMex: QConnect HIVp24

20 June 2018

IVDs, viral microbiology

MHRA reference: 2018/007/024/291/001

Fannin: Brilliance UTI Clarity Agar

23 July 2018

IVDs, bacteriology

Model: W11103

MHRA reference: 2018/007/024/601/001

Geratherm Medical: UniqueResc

27 March 2018

Heating, patient, electrical pads & blankets

Model: UniqueResc

MHRA reference: 2018/007/024/701/024

Horiba Medical: Yumizen H2500 & H2500 sPS

12 July 2018

IVDs, haematology

MHRA reference: 2018/007/025/601/005

LivaNova: Perceval Sutureless Heart Valve

18 June 2018

Implants, non active, cardiovascular heart valves

Model: PVS

MHRA reference: 2018/006/008/478/003

Medtronic: Guardian™ Connect Application

July 2018

Continuous glucose monitoring systems (CGMS)

Model: CSS7200

MHRA reference: 2018/007/005/291/044

NxStage Medical: NxStage Express Fluid Warmer

11 June 2018

Blood/fluid warming systems

Model: FW-300, FW-300-A, FW-300-WW, FW-301-A

MHRA reference: 2018/006/026/081/012

Ortho Clinical Diagnostics: VITROS: Folate, FreePSA, FSH, Prolactin & TSH

July 2018

IVDs, clinical chemistry

Model: 1513266, 6842845, 1931922, 1849793, 1912997

MHRA reference: 2018/007/023/601/001

Philips: Allura Xper, INTEGRIS systems (Poly C-OMCP- Visub / Cesar-OMCP-Visub)

16 July 2018

X Ray, fluoroscopy systems

Model: Allura Xper, INTEGRIS systems

MHRA reference: 2018/007/020/291/020

QIAGEN: EZ1 Advanced XL

23 July 2018

VD, genetic testing

MHRA reference: 2018/007/024/701/032

Reckitt Benckiser: Durex Real Feel Condom

30 July 2018

Contraceptives, barrier

MHRA reference: 2018/007/025/601/009

Seers Medical: SEERS Medical

16 July 2018

Trolleys and chairs

Model: SM3484

MHRA reference: 2018/007/004/601/006

Siemens: RAPIDPoint 405 500 and RAPIDLab 1245 1265

July 2018

IVDs, extra laboratory testing

MHRA reference: 2018/007/020/601/004

Siemens: IMMULITE 1/1000 IMMULITE 2000 PSA

July 2018.

IVDs, clinical chemistry

Model: LKPS/L2KPS, LKPTS(D) & L2KPTS(D)

MHRA reference: 2016/011/021/601/009

Siemens (Abbott): ADVIA Centuar CKMB Calibrator/Atellica CKMB Calibrator

July 2018

IVDs, haematology

MHRA reference: 2018/007/025/601/008

Spacelabs Healthcare: Arkon Anesthesia Delivery System

11 July 2018

Anaesthetic machines & monitors

Model: 99999

MHRA reference: 2018/007/024/701/017

STERIS: AMSCO V-PRO 1, V-PRO 1 Plus, VPRO maX

25 July 2018

Sterilization methods, chemical

MHRA reference: 2018/007/020/291/018

Stryker: 983031 Hoffmann LRF Hexapod Software

July 2018

Osteosynthesis, external fixators MHRA reference: 2018/007/016/291/002

The Binding Site: Human IgM Kit for use on SPAPLUS

25 July 2018

IVDs, clinical chemistry

MHRA reference: 2018/007/025/601/001

Thermo Fisher Scientific: Oxoid

20 July 2018

IVDs, bacteriology

Model: Brilliance™ UTI Clarity Agar

MHRA reference: 2018/007/024/601/009

Thermo Fisher Scientific: Remel

3 July 2018

IVDs, bacteriology

Model: R30164001

MHRA reference: 2018/007/018/601/005

Published 30 July 2018
Last updated 30 July 2018 + show all updates
  1. Added FSN for Reckitt Benckiser: Durex Real Feel Condom.
  2. First published.