China NMPA Product Recall - Tissue staining machine

Danco North America, through its agent Agilent Technologies (China) Co., Ltd., initiated a Class III voluntary recall of its Tissue Staining Machines, specifically 403 units of the Autostainer Link 48 instrument (AS480), as reported by the National Medical Products Administration (NMPA) on January 16, 2019. The recall stems from a critical issue where the Slide Holder (S3704), integral to the AS480, can experience uneven cutting. This degradation occurs due to repeated exposure to the high temperatures of the PT Link hot water bath, compromising the slide holder's leveling integrity. The primary concern is that this malfunction directly impacts staining quality, potentially causing weak or non-uniform staining. Such issues can lead to inaccurate diagnostic results, including false negatives, thereby posing a risk to patient care. In response, Danco North America has implemented several corrective actions. These include updating the Autostainer Link Basic User Guide with new recommendations. Key revised guidelines advise limiting each slide holder to a maximum of 175 PT Link pretreatment cycles, emphasizing proper storage and alignment during loading, and mandating the disposal of slide holders that either fail position tests or have exceeded their usage limit. These measures aim to mitigate the risk of slide unevenness and ensure consistent staining quality.