Field Safety Notices: 30 January to 3 February 2023
List of Field Safety Notices (FSNs) from 30 January to 3 February 2023.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Alinity m HBV AMP Kit
12 January 2023
MHRA reference: 5028007
Abbott: FreeStyle Libre 2 Sensors
February 2023
MHRA reference: 5044080
Aidapt Bathrooms: Wheelchair attendant\occupant driven collapsible
12 January 2023
Model: VA170 & VA165Silver
MHRA reference: 5023437
Aspire Pharma: Epimax
20 January 2023
MHRA reference: 5032139
B Braun: INF.SP.LINE,TRANS,PVC,LL,250CM-EU
25 January 2023
MHRA reference: 5037381
BD: Venovo Venous Stent System
10 January 2023
MHRA reference: 5044151
Bio-Rad: IH-1000
26 January 2023
MHRA reference: 5036802
DeVilbiss Healthcare: 5L Oxygen Concentrator
23 December 2022
Model: 525
MHRA reference: 5036698
GE Healthcare: NM/CT 850
18 December 2022
MHRA reference: 5026862
Ivoclar: VivaPen Snap-On Cannulas
November 2022
MHRA reference: 5041158
Leica Biosystems: BOND tm Ready-to-Use Primary Antibody Bcl-6 (LN22)
14 October 2022
MHRA reference: 5029948
Medtronic: Affinity Fusion Oxygenator TMA
December 2022
Model: BB811, BB841, CB811, CB841
MHRA reference: 5028041
Medtronic: Vanta Clinician Programmer Application
FA1260, January 2023
Model: A71200
MHRA reference: 5041176
Medtronic: Vanta / Sequentia LT Clinician Programmer Application
FA1266, January 2023
Model: A71200
MHRA reference: 5038274
Medtronic: Vanta LT Clinician Programmer Application
FA1292, January 2023
Model: A71200
MHRA reference: 5037448
Medtronic: Tri-Staple 2.0 Black Intelligent Reload
January 2023
Model: SIG60AXT
MHRA reference: 5036699
Objective Imaging: Glissando 20SL
02 February 2023
Model: 20SL 40X CE-IVD
MHRA reference: 5044043
Peninne: Link Yankauer Sets and Suction Connecting Tubing
10 January 2023
MHRA reference: 5041304
Randox: CRP
01 February 2023
MHRA reference: 5041191
Schiller Medical: DEFIGARD Touch-7
December 2022
MHRA reference: 5033044
Seegene: Allplex RV Essential Assay
14 December 2022
MHRA reference: 5026060
Siemens Healthineers: ARTIS pheno, ARTIS icono biplane/icono floor
February 2023
MHRA reference: 5044037
Siemens Healthineers: Atellica CH 930 Analyzer
January 2023
MHRA reference: 5041193
Siemens: Sysmex® CA-500/CA-600 series
February 2023
Thrombin time (TT) IVD, kit, clotting
Prolonged Thrombin Time in Combination with Test Thrombin Reagent
Model: Refer to FSN
MHRA reference: 33795093 2024/011/001/601/023
Teleflex: Rüsch EndoGuide T
January 2023
MHRA reference: 5029894
ThermoFisher Scientific: Thermo Scientific Oxoid MacConkey Agar without Salt
31 January 2023
MHRA reference: 5038225