Decrease in the potency of Tuberculin PPD RT 23 SSI 2TU

Statens Serum Institute (SSI), would like to inform healthcare professionals of a potential decrease in the potency of Tuberculin PPD RT 23 SSI 2TU. Several batches of Tuberculin PPD RT 23 SSI 2TU were tested and the test result for the product's potency after 18 months did not comply with its current registered specification for product potency. To avoid an out of stock situation of Tuberculin 2TU and in consideration of the absence of a diagnostic equivalent, the release of the lower potency batches of Tuberculin 2TU has been allowed by HSA on the basis of potency/stability data provided and an evaluation of the clinical impact of the possible lower potency. Healthcare professionals are advised to interpret the test results with caution especially in high-risk individuals. Additional diagnostic tests in such high-risk individuals may be necessary to support the tuberculin test results. Please refer to the letter for details.