Field Safety Notices: 18 to 22 November 2024
List of Field Safety Notices from 18 to 22 November 2024.
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
Beckman Coulter: Access Intact PTH (Reagent Pack)
14 November 2024
DxI 9000 Access Immunoassay Analyzer
Model: A16972
Batch/LOT: Refer to Appendix A in the FSN 24060 letter
MHRA reference: 33980685 2024/011/019/601/101
MHRA reference: 33980685 – Vigilance response form
Becton Dickinson: BD FACSLyric™ Flow Cytometers
25 November 2024
Flow cytometry analyser IVD
Model: Refer to FSN
MHRA reference: 34004369 2024/011/021/601/073
Breas Medical: Vivo 45 LS (non-US) and Nippy 4+ Devices
18 November 2024
Portable ventilator, electric
Model: Refer to FSN
MHRA reference: 33954559 2024/011/015/601/075
CEFALY Technology: Cefaly Enhanced
05 September 2024
Neurologic physiotherapy devices-other; Electrode
Model: Refer to FSN
MHRA reference: 33986095 2024/011/019/601/060
Cook Medical: Hemospray Endoscopic Hemostat
30 October 2024
Non-organic haemostatic agent, sterile
LOT number: Refer to attachment
MHRA reference: 33983609 2024/010/023/601/109
MHRA reference: 33983609 – Lot numbers
DiaSorin Inc.: LIAISON QSET Device Plus
FSN-2024-03
Calprotectin IVD, reagent
Model: Refer to FSN
MHRA reference: 33993447 2024/011/011/601/019
ICU Medical: Plum 360™ Infusion System
21st November 2024
Model: Refer to FSN
MHRA reference: 33965399 2024/011/018/601/007
NIHON KOHDEN: ECG Recording Paper
21 November 2024
Interpretive multichannel electrocardiograph
Model: NKUK-A054 and NKUK-MLSC-125
MHRA reference: 34007941 2024/011/021/601/023
MHRA reference: 34007941 - Receipt
Philips: Spectral CT, Spectral CT Plus
08 November 2024
Full-body CT system
Model: Refer to FSN
MHRA reference: 33952265 2024/011/015/601/008