China NMPA Product Recall - Automatic film making machine

Hologic Medical Technologies (Beijing) Co., Ltd., representing manufacturer Hologic, Inc., initiated a voluntary Level III recall for its Automated Slide Maker (ThinPrep 5000 Autoloader), as detailed in a report dated August 12, 2016, and published by the National Medical Products Administration (NMPA) on August 19, 2016. The recall stemmed from customer complaints indicating a low-probability issue where the device might misread barcode labels on sample bottles. This misreading would lead to an incorrect sample identification being transferred to the prepared slide, resulting in a slide with an erroneous identifier. Despite Hologic’s risk analysis concluding no actual patient harm, the potential for misidentification necessitated action under NMPA's regulatory guidance (Registration Certificate No. 国械备20151734号). The affected devices, used for preparing human cell specimens for pathological analysis, were distributed globally across regions including the USA, China, Japan, and various European countries. Hologic's required actions involve notifying all affected users about the issue and implementing field improvement measures. Field engineers will contact users directly to upgrade the barcode scanners and software on the ThinPrep 5000 Autoloader units to ensure accurate sample identification during slide preparation.