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Medical Device Alert: Reagents requiring manual handling for use in combination with Cobas c501/502 analyser manufactured by Hitachi (MDA/2012/004)

Document details:

Type: Medical Device Alert
Series No: MDA/2012/004
Audience: Healthcare professionals
Published: 9 February 2012 at 11.30
Format: Electronic 
Size: A4
Pages: 7
Price: Free
Copyright: Crown

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CAS deadlines
Action underway: 09 March 2012, action complete: 09 May 2012

Ref: MDA/2012/004 | Issued: 9 February 2012 at 11.30

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/004 or 2011/011/018/401/009.

Technical aspects
Dr Rosalind Polley or Mrs Moji Ajeneye
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7119 / 7271
Fax: 020 8754 3965
Email: rosalind.polley@mhra.gsi.gov.uk or mojisola.ajeneye@mhra.gsi.gov.uk

Clinical aspects
Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices 
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website (external link)
Further information about SABS can be found on the SABS website (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Cobas c501-502 analyser made by HitachiReagents requiring manual handling for use in combination with cobas c501/502 analyser made by Hitachi.

Multiple tests are affected, such as syphilis (TPLA) test made by Sekisui.

All supplied by Roche.

The cobas c501/ 502 laboratory analyser – manufactured by Hitachi and supplied by Roche – can run assays that are:

  • manufactured by Roche
  • manufactured by third parties and supplied by Roche –  ‘partnership assays’ (e.g. TPLA)
  • manufactured by third parties and not supplied by Roche –  ‘development assays’.

In order to run partnership and some Roche assays on the cobas c501/502 instrument, users must manually transfer reagents from original bottles into a cobas c pack MULTI cassette (manufactured and supplied by Roche). They must also re-label the cassette with a new barcode supplied with the reagent. When the analyser reads this barcode the integrated cassette volume check (ICVC – the initial level check) function is not activated. This applies to all the assays listed below:


Reagent Assay Manufacturer Cat. No. ICVC
(initial level check)
CHE Cholinesterase (Acetyl) Roche Diagnostics 11877763 216 OFF
D-BIL Direct Bilirubin Roche Diagnostics 11555413 216 OFF
GLDH3 Glutamate Dehydrogenase Roche Diagnostics 11929992 216 OFF
HBDH α-Hydroxybutyrate Dehydrogenase Roche Diagnostics 11876937 216 OFF
TRIGB Triglycerides Roche Diagnostics 11877771 216 OFF
A1MG2 Alpha-1 Microglobulin Roche Diagnostics 03576116 190 OFF
B2MG β 2-Microglobulin Roche Diagnostics 11660551 216 OFF
KAPP2 Kappa Light Chain Roche Diagnostics 11820176 316 OFF
LAMB2 Lambda Light Chain Roche Diagnostics 11820184 316 OFF
MM (EDDP) Methadone Metabolite Thermo Fisher 05178576 190 OFF
OXY Oxycodone Thermo Fisher 05179459 190 OFF
TPLA Syphilis Sekisui 04955137 190 OFF

Roche have updated the information encoded in the barcode of the syphilis (TPLA) assay such that the ICVC function will be activated for future lots, starting with lot no 628267.

Instructions for use
The instructions for use (IFU) for the affected assays on the c501/502 analyser need to be downloaded electronically via the TeleServiceNet to the customer cobas link. Instrument settings to run the syphilis and other assays on the cobas c501/502 instrument also have to be downloaded to the instrument via the cobas link. Note that the volumes described in the instrument settings should not be used for manual filling of reagent cassettes. Follow the reagent specific IFU for the cobas c501/ 502 instrument.

The use of insufficient volumes of reagent may lead to a false negative result leading to patient harm such as:

  • a missed diagnosis of syphilis
  • a delayed diagnosis of organ rejection
  • a delayed diagnosis of the end of remission for malignant lymphoma patients.

It is possible to obtain ‘valid’ but inaccurate results when there is no reagent remaining in the Roche cassette.

The MHRA has received a report of a known syphilis positive patient being reported as false negative using this combination of affected devices. Following a review of results the hospital identified the possibility of obtaining a ‘valid’ but inaccurate result where there is insufficient reagent, giving a false negative result.

The instrument settings downloaded via the cobas link contain instrument specific information for the application and do not contain customer instruction for reagent preparation. If these volumes are used reagent may deplete before the end of the run.

When running any of the assays listed above where level sensing is turned off it is possible to obtain an erroneous result without an error message.

MHRA advice on the use of IVDs in combination is published in DB2008(04).

Do not use the reagent volumes downloaded as instrument settings via the COBAS link for manual loading of cassettes.

Confirm whether initial level sensing (ICVC) is ON or OFF with your device combination. If it is OFF, ensure that you load the volume of reagent in the cassette as set out in the current instructions for use.

If you have used the affected combination of devices consider the need to review previous results including the need to recall and retest patients.

Action by

Laboratory managers
Directors of pathology
GUM clinics

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (headquarters) for information
  • Health Protection Agency (HPA) (directors)
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • General practitioners (for information)
  • Primary care trusts in England (chief executives)
  • National Screening Committee (infectious diseases in pregnancy programme)

This Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this Notice. GPs need take no further action on receipt of this Alert.

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.  Below is a suggested list of recipients.

CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Antenatal screening coordinators
  • Biochemists
  • Biomedical engineering staff
  • Biomedical science departments
  • Clinical pathologists
  • Clinical pathology directors
  • Directors of genitourinary medicine clinics
  • Genitourinary outpatient clinics
  • GUM physicians
  • Maternity units
  • Medical directors
  • Microbiologists
  • Midwifery departments
  • Neonatology departments
  • Obstetrics and gynaecology directors
  • Paediatricians
  • Purchasing managers
  • Risk managers

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Community hospitals
  • Community midwives
  • Directors of public health
  • General practitioners
  • Health visitors
  • Practice managers

Health Protection Agency
Directors for onward distribution to:

  • Collaborating centres
  • Consultants in communicable disease control
  • Divisional directors
  • Heads of department
  • Heads of health, safety and quality
  • Health protection nurses
  • HPA laboratories
  • Laboratory managers
  • Regional directors
  • Regional epidemiologists
  • Regional leads
  • Regional microbiologists
  • Risk manager
  • Safety officers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Clinics
  • Hospitals in the independent sector
  • Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Michael Thein / Mr John Burling
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim

Tel: +49 621 759 8436 / 01444 256 484
Email: michael.thein@roche.com and john.burling@roche.com
If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk
Page last modified: 16 February 2012