Field Safety Notice: 16 to 20 November 2020
List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2020.
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: ARCHITECT Active-B12 (Holotranscobalamin) Reagent (LN 3P24-28/-38), ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-11), ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-02)
12 November 2020
IVDs, clinical chemistry
MHRA reference: 2020/011/013/291/004
Arjo: Arjo Flat Dynamic Positioning System (DPS)
FSN-MAG-2020-03
Hoists and slings
Model: BA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx and LBX1033-xx, KTS0010
MHRA reference: 2020/010/007/601/003
Becton Dickinson: AlarisTM GW and GW 800 Volumetric Pumps
17 November 2020
Infusion systems
MHRA reference: 2020/011/016/291/001
Beijing Aeonmed: Ventilator
09 October 2020
Lung ventilators
MHRA reference: 2020/008/028/701/023
Beijing Aeonmed: Ventilator
13 November 2020
Lung ventilators Model: VG70
MHRA reference: 2020/011/017/291/002
Bionote: NowCheck COVID-19 Ag Test
28 October 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference: 2020/011/016/601/004
EKOS Corp - Boston Scientific: EKOS Control System 4.0
92605381-FA Ultrasound, imaging
MHRA reference: 2020/011/018/291/006
Galt Medical Corporation: Centeze® /Centesis Catheter
16 November 2020
Wound drains
MHRA reference: 2020/011/017/701/047
Hain Lifesciences: GXT NA Extraction Kit VER 1.0
GXT_NA_2020-11 IVDs, viral microbiology
MHRA reference: 2020/011/012/291/008
Leica Biosystems: NCL-L-vWF
16 November 2020
IVDs, blood transfusion
MHRA reference: 2020/011/018/601/008
Maquet (Getinge): HLS Set Advanced 5.0 or 7.0, HIT Set Advanced 7.0
FSCA-2020-10-30 Infusion & transfusion, heart lung circuits
Model: 70104.7753; 70104.9134; 70104.8127; 70106.4847; 70106.4848; 70105.2794; 70105.2797
MHRA reference: 2020/011/009/291/005
Randox Laboratories: Magnesium (Mg), Xylidyl Blue, Colorimetric Method
4 November 2020
IVDs, clinical chemistry
MHRA reference: 2020/011/006/601/005
Roche: ONLINE TDM Vancomycin Gen.3 (VANC3), 100T, ONLINE TDM Vancomycin Gen.3 (VANC3), 200T, ONLINE TDM Gentamicin Gen.2 (GENT2), 100T, ONLINE TDM Phenytoin (PHNY2), 100T, ONLINE TDM Phenytoin (PHNY2), 200T, ONLINE TDM Theophylline (THEO2), 100T, ONLINE TDM Phenobarbital (PHNO2), 200T
November 2020
IVDs, clinical chemistry
MHRA reference: 2020/011/017/487/002
Siemens: ADVIA Atelllica CH Dimension Dimension Vista
November 2020
IVDs, clinical chemistry
Model: 10335869, 10361941, 10492319, 10335872, 10325776, 10335892, 10697575, 11097533, 11319121, 11097637, 11097621, 11097614, 11532568, 11097591, 10471520, 10444906, 10700444, 10445093
MHRA reference: 2020/011/013/601/001
SimplyMed: SMM500
12 October 2020
Walking aids, crutches
MHRA reference: 2020/001/007/401/003
Smith & Nephew: T-FIX RCG Sterile Drill
24 June 2020
Surgical power tools
Model: 014771
MHRA reference: 2020/007/022/291/008
Vivostat: Vivostat Disposables - single use devices
13 November 2020
Haemostatic agents
MHRA reference: 2020/011/013/291/003