False negatives force Trinity Biotech syphilis test recall:
This article was originally published in Clinica
Trinity Biotech, based in Bray, Ireland, has recalled certain lots of its CAPTIA Syphilis G Elisa test kit. The test, which is used to detect syphilis in the blood and to screen blood and/or plasma donors, has been recalled due to the risk of providing false negatives. Shifts in the performance of lots K00841, K00842, K00838, K00839, which were sold in the US in May 2002, can result in low positive readings equivalent to negatives, says the FDA's Center for Devices and Radiological Health.
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