Field Safety Notices: 20 to 24 April 2026
List of Field Safety Notices from 20 to 24 April 2026.
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: i-STAT EG7+ cartridge, i-STAT EG6+ cartridge
March 2026
Blood gas/haemoximetry analyser IVD
MHRA reference: 39232356 2026/004/003/601/135
Arrow: Arrow Edge Hemodialysis Catheterization Product, Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter, Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, Cannon II Plus Chronic Hemodialysis Catheter, NextStep Antegrade Chronic Hemodialysis Catheter, NextStep Retrograde Chronic Hemodialysis Catheter
April 2026
Double-luman haemodialysis catheter, implantable
MHRA reference: 39270848
B·R·A·H·M·S: PlGF Plus KRYPTOR
31 March 2026
MHRA reference: 39243783 2026/004/008/601/044
BioArray Solutions: Exposure Test Carrier
15 April 2026
Optical laboratory instrument performance standard
Model: 800-00063
MHRA reference: 39265415 2026/004/014/601/097
Biofire Diagnostics: Joint Infection (JI) Panel
30 April 2026
Multiple-type respiratory pathogen nucleic acid
Model: RFIT-ASY-0138
MHRA reference: 39265127 2026/004/023/601/023
D.O.R.C. Dutch Ophthalmic Research Center: TDC VELOCE
Ref SA-2026-0004
MHRA reference: 39265307 2026/004/023/601/083
Edwards Lifesciences: Swan Ganz
Ref 198
Model: 096F6/096F6P, 131F7/131F7P, 132F5, 141F7, 151F7, 774F75, 777F8, 782F75M, 831F75/931F75P, 834F75, AIQSGF8, C144F7, C146F7, SGPT54, SGPT64P, SGPT755P, T // D200F7
MHRA reference: 39257515 2026/003/026/601/114
Epocal: Epoc BGEM Test Cards
April 2026
MHRA reference: 39232933 2026/004/003/601/012
Immucor: Panocell-16 / Capture-R Ready-ID Extend II
01 April 2026
MHRA reference: 39220741 2026/004/017/601/077 Customer Letter
MHRA reference: 39220741 2026/004/017/601/077 Distributor Letter
Kimal: Procedure packs
17 April 2026 Ref GLB101836
MHRA reference: 39224990 2026/004/017/601/048
Kimal: Procedure packs
17 April 2026 Ref GLB101838
MHRA reference: 39224898 2026/004/017/601/053
MAKO: MICS 3 Angled Sagittal Saw Attachment
April 2026
MHRA reference: 39270753 2026/002/026/601/043
Philips: Achieva 1.5T: 781178, 781196, 781296 Achieva 3.0T: 781278 Evolution Upgrade 1.5T: 782116, 782148, 782166 Evolution Upgrade 3.0T: 782143, 782162 Ingenia 1.5T: 781315, 781341, 781396, 782115 Ingenia 1.5T CX: 781262 Ingenia 3.0T: 781342, 781377, 782103 Ingenia 3.0T CX: 781271, 782105 Ingenia Ambition S: 781359, 782108, 782139 Ingenia Ambition X: 781356, 782109, 782138, 782160 Ingenia Elition S: 781357, 782106, 782137 Ingenia Elition X: 781358, 782107, 782136 MR 7700: 782120, 782153 SmartPath to dStream for 1.5T: 781260, 782112 SmartPath to dStream for 3.0T: 782145 SmartPath to dStream for XR and 3.0T: 781270, 782113 SmartPath to Ingenia Elition X: 782118, 782144, 782163 Upgrade to MR 7700: 782130Brand
13 April 2026
Magnetic Resonance Imaging (MRI) unit
MHRA reference: 39279307 2026/004/014/601/050
Philips Respironics: Trilogy Evo; Trilogy Evo O2; Trilogy EV300
13 April 2026
Portable Electric Ventilator
MHRA reference: 39257438 2026/002/011/601/010
Primus Corporation, dba Trinity Biotech: A. Menarini Premier Hb9210 Analyzer
30 March 2026
Glycated Haemoglobin (HbA1c) Analyser IVD
MHRA reference: 39232314 2024/009/030/601/081
Siemens Healthcare: Atellica CH Creatine Kinase (CK_L)
March 2026
Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Model:
MHRA reference: 39232994 2026/003/018/601/100