hii taarifa ipo siku nyingi rejea barua ya WHO 16 november 2011 Pia soma hii link ya wavuti website
Kashifa Wizara ya Afya: Mganga Mkuu ashindwa kuagiza kuondolewa vipimo vibovu vya VVU nchini - nyumbani ya WHO LINK
http://www.who.int/diagnostics_labo...1201_productalert_for_product0027_mx012.pdf20, AVENUE APPIA CH-1211 GENEVA 27 SWITZERLAND TEL CENTRAL +41 22 791 2111 FAX CENTRAL +41 22 791 3111
WWW.WHO.INTDLT/FSN.001 16 November 2011Field Safety Notice No. 1Product: SD Bioline HIV-1/2 3.0Product code: 03FK10PQDx Number: PQDx 0027-012-00The WHO Prequalification of Diagnostics programme has undertaken the WHOprequalification assessment for the SD Bioline HIV-1/2 3.0 (product code 03FK10)manufactured by Standard Diagnostics at 156-68, Hagal-dong, Giheung-ku, Yongin-si, Kyonggido446-930 Republic of Korea. The laboratory evaluation showed unacceptably high rate(approximately 50%) of invalid test devices on two separate lot numbers (023419 and 023418B)with expiry dates 30 August 2013 and 2 August 2013, respectively.The Partnership for Supply Chain Management (PSCM) has observed similar problemswith the SD Bioline HIV-1/2 3.0 (product code 03FK16) lot number 023424B with expiry date18 August 2013 and lot number 023425.SD Bioline HIV-1/2 3.0 will be de-listed from the WHO e-catalogue and will thereforenot be eligible for procurement by WHO and UN agencies, until further notice.WHO has provided Standard Diagnostics with an appropriate course of action to guidetheir investigation of the problem and the company is cooperating fully with this request.If you are experiencing similar problems, please complete the "User complaint form forreporting problems and/or adverse events related to diagnostic products" available on ourwebpages (
WHO | Procurement of diagnostics) and submit it
todiagnostics@who.int. If you have any questions, please do not hesitate to contact the WHOPrequalification of Diagnostics programme by email (diagnostics@who.int).