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
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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:
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:
Becton Dickinson: AlarisTM GW and GW 800 Volumetric Pumps
17 November 2020
Infusion systems
MHRA reference:
Beijing Aeonmed: Ventilator
09 October 2020
Lung ventilators
MHRA reference:
Beijing Aeonmed: Ventilator
13 November 2020
Lung ventilators Model: VG70
MHRA reference:
Bionote: NowCheck COVID-19 Ag Test
28 October 2020
IVDs, SARS-CoV-2 PCR Test
MHRA reference:
EKOS Corp - Boston Scientific: EKOS Control System 4.0
92605381-FA Ultrasound, imaging
MHRA reference:
Galt Medical Corporation: Centeze庐 /Centesis Catheter
16 November 2020
Wound drains
MHRA reference:
Hain Lifesciences: GXT NA Extraction Kit VER 1.0
GXT_NA_2020-11 IVDs, viral microbiology
MHRA reference:
Leica Biosystems: NCL-L-vWF
16 November 2020
IVDs, blood transfusion
MHRA reference:
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:
Randox Laboratories: Magnesium (Mg), Xylidyl Blue, Colorimetric Method
4 November 2020
IVDs, clinical chemistry
MHRA reference:
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 皇冠体育appophylline (THEO2), 100T, ONLINE TDM Phenobarbital (PHNO2), 200T
November 2020
IVDs, clinical chemistry
MHRA reference:
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:
SimplyMed: SMM500
12 October 2020
Walking aids, crutches
MHRA reference:
Smith & Nephew: T-FIX RCG Sterile Drill
24 June 2020
Surgical power tools
Model: 014771
MHRA reference:
Vivostat: Vivostat Disposables - single use devices
13 November 2020
Haemostatic agents
MHRA reference: