Field Safety Notice: 2 to 6 November 2020
List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 2020.
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
AAT: c-max 140; c-max 160; CR23
15 September 2020
Moving & handling
MHRA reference: 2020/011/003/291/017
Abbott: ARCHITECT EBV VCA IgM Calibrator
29 October 2020
IVDs, viral microbiology
MHRA reference: 2020/010/030/291/006
Across: Revolax
22 October 2020
Implants, reconstructive, body contouring
MHRA reference: 2020/010/022/601/001
CareDx Pty: AlloSeq Tx 17
23 October 2020
IVDs, immunology
MHRA reference: 2020/011/005/291/002
Chromsystems Instruments & Chemicals: 6PLUS1 Multilevel Saliva Calibrator and MassCheck Cortisol, Cortisone in saliva control level I and II
28 October 2020
IVDs, clinical chemistry
Model: 73039, 0349, 0350
MHRA reference: 2020/010/030/601/001
Farla Medical: THERM01
15 October 2020
Diagnostic measurement and monitoring
MHRA reference: 2020/010/019/291/004
GA Health Company: GAR004C, EN10229.2, ENDO004C, EN10232, GAR065, GAR3846
4 November 2020
Endoscopes, flexible
Model: Andorate Suction Valve - GAR004C, EN10229.2, ENDO004C, EN10232, GAR065, GAR3846
MHRA reference: 2020/011/004/291/002
Medtronic: CareLinkTM Software; Medtronic CareLink® Personal Therapy Management Software for Diabetes
October 2020
Software as a Medical Device (SaMD)
Model: MMT-7350, MMT-7333
MHRA reference: 2020/010/029/291/025
Microbiologics: KWIK-STIK, KWIK-STIK Plus and LYFO DISK
8 October 2020
IVDs, bacteriology
Model: Catalog 01245P Klebsiella pneumoniae derived from NCTC
MHRA reference: 2020/011/005/291/004
SENTINEL: Zinc
29 October 2020
IVDs, clinical chemistry
MHRA reference: 2020/010/030/291/001
Siemens: Atellica IM 1300 Analyzer and Atellica IM 1600
October 2020 (ASW21-01.A.OUS)
IIVDs, clinical chemistry
Model: IM1300 Analyser SMN 11066001 IM1600 Analyser SMN 11066000
MHRA reference: 2020/011/004/601/004
Siemens: ADVIA Chemistry Ammonia
October 2020
IVDs, clinical chemistry
Model: 10286035
MHRA reference: 2020/010/030/601/007
Tracoe medical: TRACOE twist plus, TRACOE experc Set twist plus
3 November 2020
Airway devices
Model: REF 316-07, REF 316-08
MHRA reference: 2020/010/027/291/002
Tsunami Medical: Titanium cage
22 October 2020
Spinal implants
Model: ACX
MHRA reference: 2020/011/005/291/003