# China NMPA Product Recall - Hologic ThinPrep 5000 Processor Autoloader

Source: https://www.globalkeysolutions.net/records/china_product_recall/hologic-inc/96ffd47d-0e01-4671-a227-23b09098b285/
Source feed: China

> China NMPA product recall for Hologic ThinPrep 5000 Processor Autoloader by Hologic, Inc. published August 19, 2016. Recall level: Level 3 Recall. Hologic Medical Technologies (Beijing) Co., Ltd. and its manufacturer, Hologic, Inc., initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hologic Technologies (Beijing) Co., Ltd. is voluntarily recalling its automated film-making machines.
- Company Name: Hologic, Inc.
- Publication Date: 2016-08-19
- Product Name: Hologic ThinPrep 5000 Processor Autoloader
- Recall Level: Level 3 Recall
- Recall Reason: An investigation into customer complaints revealed that, in extremely rare cases, the Hologic ThinPrep 5000 Processor Autoloader might misread the coded values on the barcode labels of sample vials. If this misreading occurs, the misread sample vial ID value is transferred to the slide, effectively creating a slide with an incorrect identifier.
- Discovering Company: Hologic Technologies (Beijing) Co., Ltd.
- Manufacturing Company: Hologic, Inc.
- Summary: Hologic Medical Technologies (Beijing) Co., Ltd. and its manufacturer, Hologic, Inc., initiated a voluntary Level III recall for their Automated Slide Maker (Hologic ThinPrep 5000 Processor Autoloader), as reported by the National Medical Products Administration (NMPA) on August 19, 2016. The recall was prompted by findings from customer complaint investigations, revealing that the device could, with a very low probability, misread barcode labels on sample bottles. This issue results in the transfer of an incorrect sample bottle identification value to the prepared slide, effectively creating a slide with an erroneous identifier. Despite Hologic’s risk analysis concluding no actual patient risk, the company is implementing corrective actions under the NMPA's regulatory framework. Required actions include notifying all affected users of the issue and deploying field improvement measures. Field engineers will directly contact users to upgrade the barcode scanners and software on the affected units to rectify the misreading problem, ensuring accurate sample identification and maintaining diagnostic integrity across all impacted regions, including China, the USA, and various European nations.

Company: https://www.globalkeysolutions.net/companies/hologic-inc/bf654f75-4802-4fb4-9387-5706aec9ac0d/