China NMPA Product Recall - Prenatal screening data management software (product name: LifeCycleTM)

Finnish company Wallac Oy initiated a voluntary recall for its LifeCycleTM prenatal screening data management software (Version 4.0, revisions 2, 3, and 4) following an internal discovery. The issue, reported to China's National Medical Products Administration (NMPA) on May 4, 2016, by distributor PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd., involves an incorrect parameter definition within a proportional equation for the Duct Venous Pulsatility Index (DVPI). The software mistakenly uses 'crl' instead of 'crl-65', leading to significant inaccuracies. Specifically, when a pregnant woman's DVPI measurement is high (equal to or greater than 1.5), the calculated risk value becomes approximately four times higher than expected, potentially prompting unnecessary confirmatory testing or medical interventions. Wallac Oy confirmed no adverse events were reported due to this error and assessed the likelihood of harm as "very unlikely." Under NMPA's regulatory oversight (CFDA (Imported) 2013 No. 270), required actions include advising clients to immediately discontinue using the DVPI parameter in routine screening and to recalculate high-risk results (DVPI 1.5) after disabling the parameter. PerkinElmer committed to providing a free software upgrade, expected by April 2016, to rectify the defect, while the NMPA requested provincial administrations to enhance supervision.