Field Safety Notice - 7 to 11 August

Summary List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 August 2017


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

Abbott: Abbott RealTime HIV-1 Qualitative

8 August 2017

IVDs, viral microbiology

MHRA reference: 2017/008/010/701/002

Abbott: Abbott RealTime HIV-1 Amplification Reagent Kit

8 August 2017

IVDs, viral microbiology

MHRA reference: 2017/008/010/701/003

Biomet: CPT Stem (Zimmer) and Novae Stick Cup (Serf Dedienne)

7 April 2017

Joint prosthesis, hip

MHRA reference: 2015/008/020/291/010

Datascope: Datascope Intra-Aortic Balloon Pump

17 July 2017

Cardiac assist pumps

Model: CS100, CS100i and CS300 IABP

MHRA reference: 2017/007/018/291/020

Elekta: Oncentra Brachy 4.5

August 2017

Radiotherapy planning and verification

Model: 170.730

MHRA reference: 2017/008/010/701/014

FUJIFILM: FDR-1000AWS / FDR-2000AWS / FDR-3000AWS / CR-IR363

FFUID 201707070


MHRA reference: 2017/008/010/071/020

Haemonetics: Cell Saver Elite (70ml) / Cell Saver 5/5+ (70ml)

2 August 2017

Infusion & transfusion, autologous

Model: Cell Saver Elite (70ml) / Cell Saver 5/5+ (70ml)CSE-P-70; 0291E-00

MHRA reference: 2017/008/008/701/018

Implant Direct: Spectra-System®/ Legacy™ Guided Surgery Handle Kit

26 June 2017

Surgical power tools

Model: G-HK

MHRA reference: 2017/007/027/601/010

Instrumentation Laboratory: HemosIL ReadiPlasTin

2 August 2017


Model: HemosIL ReadiPlasTin

MHRA reference: 2017/008/008/291/045

Merck: Bioscot Anti-Fyb monoclonal human IgM blood grouping reagent (cell line SpA264LBg1)

August 2017

IVDs, blood transfusion

MHRA reference: 2017/008/004/601/022

Phadia (ThermofisherScientific): ImmunoCap

Quality Information QI2017-07 ImmunoCAP Allergen f205, Herring

IVDs, immunology

MHRA reference: 2017/007/025/601/008

Randox: Immunoassay Premium Plus Quality Control, Immunoassay Premium Quality Control

24 July 2017

IVDs, clinical chemistry

Model: IA3109, IA3110, IA3111, IA3112, IA2638, IA2639, IA2640, IA2633

MHRA reference: 2017/008/004/601/011

Randox Laboratories: Lipid Control Level 3

7 August 2017

IVDs, clinical chemistry

Model: LE2670

MHRA reference: 2017/008/008/601/011


28 June 2017

IVDs, immunology

Model: 2100, 2300, 2600

MHRA reference: 2017007/027/291/028

Smiths Medical: UniPerc® Adjustable Flange Tracheostomy Tube

7 August 2017

Airway devices

Model: 100/897/080 CZ

MHRA reference: 2017/008/008/291/013

Stryker: Various Stryker Hip products

28 July 2017

Joint prosthesis, hip

MHRA reference: 2017/007/027/291/018

Zoll: ZOLL 731 Ventilator

30 June 2017

Lung ventilators

Model: EMV+, AEV, Eagle II, and Eagle II MRI

MHRA reference: 2017/008/010/701/012

Published 14 August 2017