China NMPA Product Recall - Total Human Chorionic Gonadotropin B Subunit II Assay Kit (Chemiluminescence Method) and Total Human Chorionic Gonadotropin B Subunit II Calibrator (Chemiluminescence Method)

Ortho Clinical Diagnostics (China) Co., Ltd. initiated a voluntary Class II medical device recall, reported on March 1, 2016, and announced on April 21, 2016, under the National Medical Products Administration (NMPA). The recall pertains to specific batches of their Total Human Chorionic Gonadotropin (HCG) Subunit II Assay Kit (Chemiluminescence Method) and its corresponding Calibrator.The central issue identified was a "Positive Bias in Results" when samples were tested using the VITROS® system. Specifically, patient samples that should have exhibited very low or undetectable hCG levels (below 2.39 mIU/mL) were inaccurately reported with elevated results, close to 7.40 mIU/mL. This discrepancy could lead to misinterpretation of patient hCG levels. The affected batches include 6802220 (Batch Nos. 1420, 1480) and 6802221 (Batch Nos. 1420, 1480).The required corrective action instructs all users to immediately discontinue use and discard any remaining stock of the identified calibrators and reagent kits from these batches. Ortho Clinical Diagnostics committed to providing replacement products expeditiously.