Field Safety Notices: 2 to 6 August 2021
List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 August
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: Vysis CLL FISH Probe Kit
4 August 2021
IVD, genetic testing
MHRA reference: 2021/008/006/000/010
Abbott Laboratories: Alinity ci-series System Control Module (SCM)
26 July 2021
IVDs, clinical chemistry
MHRA reference: 2021/007/029/291/005
Armstrong Medical: 2105489-003 AMSORB PLUS PREFILLED G-CAN 1.0L
3 August 2021
Gas absorbers
Model: AMAB3801 and AMAB3801GE
MHRA reference: 2021/007/026/487/007
Beckman Coulter: Remisol Advance
22 July 2021
IVDs, haematology
Model: DiffPad
MHRA reference: 2021/007/027/601/001
Becton Dickinson: Needle Free Valve
3 August 2021
Infusion & transfusion, connectors
MHRA reference: 2021/006/029/291/013
Boston Scientific: TheraSphere Administration Sets
29 July 2021
Infusion & transfusion, administration sets
MHRA reference: 2021/007/030/487/001
Coloplast: Supraflow supra-pubic drainage set
27 July 2021
Urinary catheters and accessories
MHRA reference: 2021/007/027/291/008
Elekta: Monaco RTP System
August 2021
Radiotherapy planning and verification systems
MHRA reference: 2021/008/006/000/009
GAMA Healthcare: Clinell Universal Wipes
26 July 2021
Disinfectants for medical devices
Model: CW200
MHRA reference: 2021/005/005/601/530
Olympus Medical Systems: Forceps/Irrigation Plug (Isolated Type)
2 August 2021
Endoscopes, flexible
Model: MAJ-891
MHRA reference: 2021/007/029/291/023
PROCEPT BioRobotics Corporation: AquaBeam Handpiece
9 July 2021
Therapy tissue ablation
Model: HP2000
MHRA reference: 2021/007/023/701/058
Randox Laboratories: Calibration Serum Level 3
29 March 2021
IVDs, clinical chemistry
Model: CAL2351
MHRA reference: 2021/007/027/601/500
Roche Diagnostics: Accu-Chek Aviva, Performa and Inform II test strip
22 July 2021
IVDs, self / home testing
MHRA reference: 2021/007/021/291/002
Roche Diagnostics: cobas SARS-CoV-2 & Influenza A/B
SBN-RDS-POC-2021-010
IVDs, SARS-CoV-2 PCR test
MHRA reference: 2021/007/030/487/003
SureScreen Diagnostics: Antigen Rapid Test
29 July 2021
IVDs, SARS-CoV-2 lateral flow antigen test
Model: COVID19AGVCT, COVID19AGVCQR
MHRA reference: 2021/007/029/601/005