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| Issued: 24 June 2008 at 13:45 |
Ref: MDA/2008/043
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Pregnancy test kits– Clinitest hCG Cassette, lot numbers 97552 and 97574 (professional use only), manufactured by Siemens Healthcare Diagnostics. |
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| Problem: Recall due to the potential for false negative results. |
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| Action by: Healthcare personnel using or distributing this device. Healthcare personnel treating patients based on results from these test kits. |
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Action: |
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Distributed to:
* via CE Bulletin |
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| 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. |
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| Appendix: Manufacturer’s recall letter (in pdf only). |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 01 July 2008
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Deadline (action complete): 15 July 2008
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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 
