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MDA/2007/036 - Urine test strips: Makromed - all products with expiry dates in 2007 or 2008

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/036
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 16 May 2007 at 14:30
Ref: MDA/2007/036


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Urine test strips: Makromed - all products with expiry dates in 2007 or 2008.

>Page 2

Problem:
Potential for misdiagnosis due to false negative results when testing for blood or ketones in urine.

>Page 2

Action by:
Healthcare personnel supplying, using or managing these devices.
Staff making clinical decisions based on the results of these devices.		  

Action:

  • Do not use affected product
  • Identify and quarantine all remaining stock of affected product
  

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Health Protection Agency (HPA) - Directors

* via CE Bulletin

>Pages 2-3

Contacts:
Details of UK distributor, manufacturer and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Page 3

Appendix:
Appendix 1 – List of affected batches with expiry dates (in pdf only)
Appendix 2 – Sterilab Services’ recall letter to UK customers. (in pdf only)

>Pages 5-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 30 May 2007
Deadline (action complete): 16 July 2007


Page last modified: 16 May 2007