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| Issued: 08 March 2007 at 11:00 |
Ref: MDA/2007/020
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Immediate action |
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Action |
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Update |
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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. |
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| Problem: Increased risk of false negative results. |
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| Action by: Healthcare personnel supplying, using or managing these devices. Medical staff treating patients based on the results of these devices. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and MHRA contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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| Appendix: Manufacturer’s recall letter dated 14/2/07 and supplementary information dated 1/3/07 (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 15 March 2007
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Deadline (action complete): 22 March 2007
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MDA/2007/020 - Coagulation point of care test: Clearview Simplify D-dimer 
