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

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

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

England Northern Ireland Scotland Wales
Device Problem Action Distribution Manufacturer Feedback

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: and requesting this facility.

Document details:

Type: Medical Device Alert
Series No: MDA/2012/004
Audience: Healthcare professionals
Published: 09 February 2012 at 11:30
Format: Electronic 
Size: A4
Pages: 7
Price: Free
Copyright: Crown
Page last modified: 16 February 2012