China NMPA Product Recall - Intestinal bacteria agar medium

Jinan Baibo Biotechnology Co., Ltd. initiated a Class III voluntary recall of its Enteric Bacteria Agar Culture Medium (MacConkey Agar Medium, 90mm). The recall was reported by the company on August 25, 2017, and published by the National Medical Products Administration (NMPA) on September 8, 2017. The issue stemmed from an operational error by production personnel, resulting in the incorrect printing of the expiration date on product labels for two specific batches (17072201 and 17072202). A total of 1,030 units were affected, primarily sold in Qingdao, Shandong, China. While the company asserted that the labeling discrepancy did not compromise the product's functionality or customer safety, it represented a critical non-compliance with regulatory requirements. The product holds a registration under the "Lu Food and Drug Administration Medical Device (Approval) No. 2013 Certificate Code: 2400508." In response, Jinan Baibo Biotechnology was directed to send formal letters to all affected customers, instructing them to discontinue using the identified product batches. Additionally, the company was mandated to retrieve all sold products from these batches and facilitate comprehensive returns and exchanges. This incident underscores the paramount importance of meticulous labeling to uphold medical device standards.