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MDA/2007/052 - Pregnancy test kits: Clearview HCG, product code 500158, lot number HG0050

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Document details:

Type: Medical Device Alert
Series No: N/A
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Related information:

MHRA pages:

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Page 1

Issued: 12 June 2007 at 14:00
Ref: MDA/2007/052

 

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Immediate action
 
Action
 
Update
 
Information request


Device:
Pregnancy test kits: Clearview HCG, product code 500158, lot number HG0050.

 >Page 2

Problem:
Possibility of false negative pregnancy test results.

 >Page 2

Action by:
Healthcare personnel using or distributing this device.		  

Action:

  • Do not use lot HG0050 of the affected product.
  • Quarantine and dispose of all affected product in accordance with the manufacturer’s recall letter (see appendix - in pdf only).
  • Develop a local policy for the review of patients tested with affected product.
  

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 (in pdf only).		  

 >Pages 5-6



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 14 June 2007
Deadline (action complete): 26 June 2007


Page last modified: 12 June 2007