Update information on the SD Bioline HIV-1/2 v3.0 In November 2011, the World Health Organization issued a Field Safety Notice advising that its Prequalification of Diagnostics Programme had found an unacceptably high rate of invalid test results with devices of certain lots of SD Bioline HIV-1/2 3.0 (product code 03FK10) manufactured by Standard Diagnostics at 156-68, Hagal-dong, Giheung-ku, Yongin-si, Kyonggi-do 446-930, Republic of Korea.
The problem:
The devices giving invalid test results show a substantial red background colour in the test window where results are read. This blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. This means that no test result can be given, rendering the test invalid. A valid negative test result shows one line, i.e. the control line (C) on a clear background. A valid positive result may show either two or
three lines, i.e. the control line (C) and one or two test lines (T1 and/or T2) , indicating respectively HIV-1 and/or HIV-2.
Action by Standard Diagnostics:
Standard Diagnostics conducted a root-cause analysis, as recommended by WHO, of the defect at the Korean facility. Subsequently, the company issued voluntary recalls of all lots identified as defective during the course of the investigation. These are: 023418, 023418B, 023419, 023424, 023424B, 023425B, 023426B, 023427, 023427B, 023428, 023428B, 023429B, 023430, 023430B.
Additional defective lot numbers have since been identified: 023413B, 023425, 023426, and 023429. WHO recommendations:
Any pending procurement of the product should be cancelled, and no new procurements initiated until further notice.
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The problem:
The devices giving invalid test results show a substantial red background colour in the test window where results are read. This blurs the visibility of the test lines and therefore makes correct interpretation of the test result impossible. This means that no test result can be given, rendering the test invalid. A valid negative test result shows one line, i.e. the control line (C) on a clear background. A valid positive result may show either two or
three lines, i.e. the control line (C) and one or two test lines (T1 and/or T2) , indicating respectively HIV-1 and/or HIV-2.
Action by Standard Diagnostics:
Standard Diagnostics conducted a root-cause analysis, as recommended by WHO, of the defect at the Korean facility. Subsequently, the company issued voluntary recalls of all lots identified as defective during the course of the investigation. These are: 023418, 023418B, 023419, 023424, 023424B, 023425B, 023426B, 023427, 023427B, 023428, 023428B, 023429B, 023430, 023430B.
Additional defective lot numbers have since been identified: 023413B, 023425, 023426, and 023429. WHO recommendations:
Any pending procurement of the product should be cancelled, and no new procurements initiated until further notice.
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