China NMPA Product Recall - Automated film processing machine (Hologic ThinPrep 5000 Processor Autoloader / ThinPrep 5000 Autoloader)

Hologic Medical Technology (Beijing) Co., Ltd., on behalf of manufacturer Hologic, Inc., initiated a Class III voluntary recall of its Hologic ThinPrep 5000 Processor Autoloader, as reported by the National Medical Products Administration (NMPA) on August 29, 2016. This action followed an investigation into customer complaints, which revealed a low-probability issue where the automated slide maker might misread encoded values on barcode labels. Should this occur, an incorrect sample identifier would be transferred to the prepared slide, resulting in a mislabeled slide.

The recall affects specific serial numbers of the ThinPrep 5000 Autoloader across numerous countries and regions, including the USA, China, Japan, several European nations, New Zealand, and Australia. Despite the potential for misidentification, Hologic's risk analysis concluded there is no actual patient safety risk, and the device can continue to be used. As a corrective measure, Hologic is notifying all affected users and dispatching field engineers to implement software and barcode scanner upgrades on the affected units, thereby resolving the misreading issue.