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

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

Updates to this page

Published 9 November 2020