Field Safety Notice - 7 to 11 August
Summary List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 August 2017
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
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
Mammography
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
Coagulation
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
SEBIA: MINICAP IMMUNOTYPING, CAPILLARYS IMMUNOTYPING, CAPI 3 IMMUNOTYPING
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