China NMPA Product Recall - Calibrators for biochemical analyzers

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall for specific calibrators used in biochemical analyzers, specifically affecting batch number 0954. This action was reported to the National Medical Products Administration (NMPA) on November 23, 2015, with public announcement on December 15, 2015. The manufacturer of these calibrators, registered under CFDA (Imported) No. 20143403127, is Ortho-Clinical Diagnostics, Inc. The core issue driving the recall is the potential for increased U90-382 or 6LU status codes, indicating a "cleaning error," during the use of these calibrators. This error primarily impacts digoxin and phenytoin assay dry tablets, causing the VITROS® system to block and prevent result reporting. However, if no cleaning error occurs and quality control results are acceptable, numerical results obtained are considered valid. To address this, users globally, including those in China where 12 boxes were sold, are instructed to immediately cease using and destroy all remaining stock of the biochemical analyzer calibrator from lot 0954 upon receiving replacement orders. Additionally, when using the new batch, it is mandatory to recalibrate digoxin and phenytoin assay dry tablets to ensure precision and reliability in diagnostic testing.