Field Safety Notices: 10 to 14 October 2022
List of Field Safety Notices (FSNs) from 10 to 14 October 2022
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: Cholestech LDX Test Cassettes
29 July 2022
IVDs, Extra Laboratory Testing
MHRA reference: 2022/008/003/601/500
Acumed: Acu-Loc® 2 CORE Full Trial VDR Platter
19 September 2022
Joint Prosthesis, Misc
Model: 80-1997
MHRA reference: 2022/009/019/601/500
B Braun: GELITA-TAMPON (Several, see Point 8)
10 October 2022
Haemostatic Agents
Model: 2070014; 2070103; 2070154; 2070600; 2070707
MHRA reference: 2022/010/010/601/004
Boston Scientific
03 October 2022
Implants, Active, Cardiac Subcutaneous system
Model: A209 - A219
MHRA reference: 2022/010/013/596/001
Boston Scientific: ORISE™ Gel Submucosal Lifting Agent
10 October 2022
Endoscopes, Flexible
MHRA reference: 2022/010/011/596/002
Gelita Medical: Tuft-it
08 September 2022
Haemostatic Agents
MHRA reference: 2022/009/013/601/501
LeMaitre: Syntel Silicone Over the Wire Embolectomy Catheter
30 September 2022
Vascular Cannula And Catheters
MHRA reference: 2022/009/001/601/004
MicroVention Terumo: WDC-2: Web Detachment Controller
20 September 2022
Vascular plug / occluders
Model: WDC-2
MHRA reference: 2022/009/020/601/002
One lambda: LinkSēq™ HLA-ABCDRDQDP+ 384 Typing Kit
06 October 2022
IVDs, Immunology
MHRA reference: 2022/010/007/611/002
Ortho Clinical Diagnostics: VITROS HIV Combo Reagent Pack 6842779 and 6842780
05 September 2022
IVDs, Viral Microbiology
MHRA reference: 2022/009/006/601/502
Randox: Serology I Positive Control
02 August 2022
IVDs, Clinical Chemistry
Model: SR10352
MHRA reference: 2022/010/010/601/502
Siemens Healthineers: Lithium_2 (LITH_2) reagents Lithium (Li) reagents
September 2022
IVDs, Clinical Chemistry
Model: Atellica CH Lithium_2 (LITH_2) 11532401 Atellica CH Lithium (Li) 11097535
MHRA reference: 2022/009/022/601/500