China NMPA Product Recall - Alkaline phosphatase assay kit (NPP substrate-AMP buffer method)

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level Three recall of its Alkaline Phosphatase Assay Kit (NPP substrate-AMP buffer method) in China, as announced by the National Medical Products Administration (NMPA) on January 14, 2021. The recall was prompted by a critical labeling discrepancy concerning the kit's open-bottle stability. The English instructions specified a 7-day stability period for use with the AU5800 instrument, while the Chinese instructions erroneously stated 14 days for all AU5800 models, lacking instrument-specific detail. No explicit inspection dates were provided, as this was a company-initiated action. Under the NMPA's regulatory guidance, Beckman Coulter is required to issue a "Medical Device Recall" notice to distributors, instructing them to notify customers about the issue. This particular recall does not involve the physical return of products. Distributors must isolate any unsold reagents from the affected batches and communicate the incident and subsequent measures taken. Furthermore, the company must add a "Customer Safety Instruction Certificate" to all subsequently produced and sold reagents and update and register a revised instruction manual to reflect the accurate stability information, ensuring consistent and correct product details for users.