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MDA/2007/020 - Coagulation point of care test: Clearview Simplify D-dimer

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/020
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 08 March 2007 at 11:00
Ref: MDA/2007/020


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Coagulation point of care test: Clearview Simplify D-dimer.
Kit lot numbers PT030A and PT031A containing test devices of batch number 682-024.

>Page 2

Problem:
Increased risk of false negative results.

>Page 2

Action by:
Healthcare personnel supplying, using or managing these devices.
Medical staff treating patients based on the results of these devices.		  

Action:

  • Stop using affected product
  • Identify and quarantine all remaining stock of affected product.
  • Consider the need to review patients previously tested negative with affected product.
  • Follow the actions set out in the manufacturer’s two notices (see appendix in pdf only).
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2

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

 >Page 3

Appendix:
Manufacturer’s recall letter dated 14/2/07 and supplementary information dated 1/3/07 (in pdf only).		  

 >Pages 4-6



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 15 March 2007
Deadline (action complete): 22 March 2007


Page last modified: 08 March 2007