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