Alerta De Seguridad para TDX / TDXFLX Dilution Buffer - ANVISA Register 10055310616 - Lots 19025Q100. 13173Q100 and (11335Q100, the only one affected in Brazil)

Safety alert

798

2005-01-24

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

It was found that the tdx-tdxflx dilution buffer, when used with the tdx-tdxflx benzodiazepines (urine) assay, may cause changes in control values ​​and patient outcomes. preliminary results from an ongoing investigation indicated that the occurrence is associated with the vial in which the tampon was filled. the magnitude of the effect is directly proportional to the time the buffer is stored in the bottle. studies in abbott have shown that the occurrence does not affect other tdx-tdxflx assays. when using a single batch of tdx-tdxflx dilution buffer, you may observe that the test control values ​​and patient results decline in the absence of recalibration. when introducing a new batch of tdx-tdxflx dilution buffer, and values ​​are read from a stored calibration curve, increasing or decreasing changes in control values ​​and patient outcomes may be observed. the magnitude of the change observed during internal testing was 33.4 ml at 200 ng / ml of 25.7 ng / ml and 26.6 ng / ml at 1000 ng / ml. according to the labeling of the product, the tdx-tdxflx benzodiazepines test provides only initial analytical results. a more specific alternative chemical method should be used to obtain a confirmed analytical result. there were no claims, damages or medical events that could be attributed to this occurrence.

Customer letter with label for each system (with Return of Receipt - AR) and Quality Policy for the Customer Service Center. Actions Needed: During the use of a single batch of buffer, recalibrate the TDx-TDxFLx Benzodiazepines assay every 14 days. Perform a new calibration on the TDx-TDxFLx Benzodiazepines test when a new TDx-TDxFLx lot number is used. Dilution Buffer. These actions are in addition to the calibration and quality control requirements of the instructions for use. Follow your laboratory procedures for notification to the health professionals you serve. If the TDx-TDxFLx Dilution Buffer (list number 9519-02) and / or TDx-TDxFLx Benzodiazepines (list number 9674) has been sent to another laboratory, provide a copy of the letter and inform all operators of the TDx-TDxFLx System about this release. For future reference, insert the notice in the TDx-TDxFLx system operation manual