Field Safety Notices - 20 July - 24 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 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
FSNs before this date are on the National Archives Website
Abbott: Alinity hq Analyzer
20 July 2020
IVDs, haematology
MHRA reference: 2020/007/022/291/002
Baxter Healthcare: EVO IQ Large Volumetric Pump
23 July 2020
Infusion systems
Model: ELVP001UKI
MHRA reference: 2020/007/017/487/013
Depuy Synthes: Specialist® 2 Distal Femoral Cutting Block
13 July 2020
Orthopaedic surgical instruments - insertion/extraction tools
Model: 966115
MHRA reference: 2020/007/009/291/001
Fast Track Diagnostics: FTD Viral meningitis
July 2020
Siemens material number: 10921724 / 10921725
Model: Siemens Material Number: 10921724 / 10921725
MHRA reference: 2020/007/017/487/014
Inpeco: Accelerator A3600 – Update FSN 30/03/2020 to 03/04/2020
14 July 2020
IVDs, clinical chemistry
MHRA reference: 2020/003/031/291/002
Maquet Critical Care (Getinge): SoKINOX; SERVINO
20 July 2020
Lung ventilators
Model: SERVINO NO Delivery and Monitoring System
MHRA reference: 2020/007/022/291/001
Ortho Clinical Diagnostics TBIL-ALKP: Brand
TBIL-ALKP 2020
IVDs, clinical chemistry
Model: 8159931, 8383051, 6844296
MHRA reference: 2020/007/020/601/002
Ortho Clinical Diagnostics: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagen
2020
IVDs, SARS-CoV-2 immunoassay (serology)
Model: 6199922
MHRA reference: 2020/007/020/601/004
Ortho Clinical Diagnostics XT System: VITROS XT3400 and XT7600 Systems
XT System 2020
IVDs, clinical chemistry
Model: 6844458 & 6844461
MHRA reference: 2020/007/022/601/003
Roche Diagnostics: Elecsys PTH (1-84)
16 July 2020
IVDs, clinical chemistry
MHRA reference: 2020/007/017/701/021
Smiths Medical: Parapac Plus Kit Without Internal PEEP & CPAP
21 July 2020
Lung ventilators
Model: P300NGB
MHRA reference: 2020/007/023/487/003
Steripack: Syringe 10 ml with 0,9% sodium chloride (5ml fill)
15 July 2020
Vascular cannula/catheter accessories
MHRA reference: 2020/006/002/291/001
Teleflex Medical: Pleur-evac® Chest Drainage Systems
06 July 2020
Chest drains and accessories
MHRA reference: 2020/007/008/487/001