Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Page 1
| Issued: 16 May 2007 at 14:30 |
Ref: MDA/2007/036
|
|
|
Immediate action |
|
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:
|
|||||||||||
|
Distributed to:
* 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
|
MDA/2007/036 - Urine test strips: Makromed – all products with expiry dates in 2007 or 2008 
