Please be informed of a quality issue with the HIV Rapid Diagnostic Test SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics (Republic of Korea).
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PRs should suspend*all pending orders for this product, and follow the steps below.
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Background information
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We were alerted by PFSCM (VPP procurement agent) of a problem during*quality control testing of the SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics (Republic of Korea).* The problem relates to an unacceptably high rate of invalid test devices.* This problem has been detected in several lots.* We immediately contacted the WHO Prequalification of Diagnostics programme, our technical partner in WHO for all diagnostics quality issues, and they were able to confirm that they had observed a similar problem during re-assessment for prequalification.* WHO contacted the company and instructed them on a course of action to investigate the quality issues; these investigations are still undergoing.
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Based on the current information available :
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WHO Prequalification*of Diagnostics Programme has issued a field safety notice which was published on their website.
http://www.who.int/diagnostics_laboratory/procurement/111201_productalert_for_product0027_mx012.pdf
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SD Bioline HIV-1/2 3.0 (product code 03FK10) has been de-listed from the List of HIV diagnostics eligible to tender for procurement by WHO in 2011, *and therefore can no* longer be purchased with the Global Fund resources.
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The company itself is voluntarily recalling several lots that were also detected as defective.
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The Global Fund analysed the PQR entries and*identified number of countries that have purchased this product in 2010 and 2011 . Please find table below summarizing the purchases of SD Bioline HIV-1/2 3.0 reported in the PQR database.* For easy reference we have copied below the list of countries concerned:
Belarus, Benin, Burkina Faso, Honduras, India, Jamaica, Liberia, Malawi, Mongolia, Nepal, Philippines, Rwanda, Sierra Leone, Somalia, South Africa, Sudan, Tanzania (United Republic), Togo, Ukraine, Zimbabwe.
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Recommended actions for countries:
Based on information available, QADM team would like to request*that all the countries listed above*be informed as soon as possible*that quality issues have been detected with SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics.*
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The Global Funds recommends the following:
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PRs should suspend*all pending orders for SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics;
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PRs who have procured and are using*this product should:
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follow the recommendations issued by WHO Prequalification of Diagnostics programme, as per the field safety notice posted on WHO website:
Field Safety Notice No. 1 SD Bioline HIV 1/2 3.0 (Standard Diagnostics).pdf*
User complaint form for reporting problems and/or adverse events related to diagnostic products.doc
recall the following affected lots , as indicated by the manufacturer Standard Diagnostics: *023426B, 023427, 023427B, 023428, 023428B, 023430, 023430B, 023418, 02418B, 023419, 023424, 023424B, 023425B, contacting the manufacturer with filled form as instructed in the following advisory notices:
Standard Diagnostics Advisory Notice Recall, dated 25 November 2011.pdf**
Standard Diagnostics Advisory Notice Recall, dated 21 November 2011.pdf*
arrange for procurement of *an alternative product. Selection to be done depending on the country's national validated testing algorithm and Global Fund quality assurance Policy : including HIV diagnostic products eligible for procurement according to WHO evaluation (List of HIV diagnostics eligible to tender for procurement by WHO in 2011,
http://www.who.int/diagnostics_laboratory/procurement/111117_hiv_products_2011_v5.pdf)* and/or other products compliant with the Global Fund Quality Assurance Policy (.i.e. authorized for use by a regulatory authority member of GHTF). For any technical assistance you can contact Ms Anita Sands*
sandsa@who.int from WHO Prequalification of Diagnostics Programme: **
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Should there be stocks* of other lots - not specified in this note- of* SD Bioline HIV-1/2 3.0 (product code 03FK10) in the programme, please send us the relevant information: batch number/s, quantity of tests in stock, and a copy of the national algorithm.*
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We are aware of the disruption for programmes if the use of this product is stopped now, however, the use of defective RDTs*could be extremely*detrimental and therefore we recommend the PRs to take immediate action.
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For any additional question or information, Principal Recipients can contact the*WHO Prequalification of Diagnostics Programme: *Ms Anita Sands*
sandsa@who.int*and the Global Fund: Joelle Daviaud
joelle.daviaud@theglobalfund.org or Carmen Perez Casas
Carmen.PerezCasas@theglobalfund.org*for any additional information.