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MDA/2008/043 - Pregnancy test kits – Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/043
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: 24 June 2008 at 13:45
Ref: MDA/2008/043

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Pregnancy test kits– Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics.

>Page 2

Problem:
Recall due to the potential for false negative results.

>Page 2

Action by:
Healthcare personnel using or distributing this device. Healthcare personnel treating patients based on results from these test kits.		  

Action:
1. Do not use affected lots. Discard any unused cassettes from affected lots.
2. Identify patients who have had negative pregnancy test results using these affected lots who are undergoing, or due to start, contraindicated therapies in pregnancy.
3. Consider repeating testing where clinically appropriate.

  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
NHS Boards in Scotland - Chief Executives

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer/supplier 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).		   >Page 5 


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 01 July 2008
Deadline (action complete): 15 July 2008

Page last modified: 01 July 2008