China NMPA Product Recall - Phosphorylated Insulin-like Growth Factor Binding Protein Detection Kit (Immunochromatography)

Alere (China) Medical Devices Co., Ltd. initiated a voluntary Class III recall for specific batches of its Phosphorylated Insulin-like Growth Factor Binding Protein Assay Kit (Immunochromatography), also known as the Actim Partus Test, manufactured by Oy Medix Biochemica Ab of Finland. The recall, publicly announced on March 10, 2015, was prompted by the discovery that certain product batches exhibited increased nonspecific binding during the latter stages of their 24-month shelf life. This issue significantly raised the likelihood of false positive results when the kit was used for in vitro qualitative determination of a protein in cervical secretions, a test vital for assessing the risk of premature birth. While false positive results were deemed not to cause direct patient harm, they necessitated additional, potentially unnecessary, medical monitoring.Under the oversight of the National Medical Products Administration (NMPA), the core corrective action, which took effect on December 15, 2014, involved reducing the shelf life for all affected products from 24 months to 13 months. Alere (China) also required the immediate issuance of an "On-site Corrective Notice" to all distributors. This notice provided details on the affected product, specific batch numbers, and the updated shelf life, with explicit instructions for distributors to relay this crucial information to all end-users. These corrective measures are to remain in place until the underlying cause of the increased nonspecific binding is fully identified and permanently resolved.