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

Source: https://www.globalkeysolutions.net/records/china_product_recall/hologic-inc/cfdd71e6-dd2c-45c8-b224-ce1e629213ab/
Source feed: China

> China NMPA product recall for Automated film processing machine (Hologic ThinPrep 5000 Processor Autoloader / ThinPrep 5000 Autoloader) by Hologic, Inc. published August 29, 2016. Recall level: Level 3 Recall. Hologic Medical Technology (Beijing) Co., Ltd., on behalf of manufacturer Hologic, Inc., initiated a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hologic Technologies (Beijing) Co., Ltd. voluntarily recalls automated film-making machines.
- Company Name: Hologic, Inc.
- Publication Date: 2016-08-29
- Product Name: Automated film processing machine (Hologic ThinPrep 5000 Processor Autoloader / ThinPrep 5000 Autoloader)
- Recall Level: Level 3 Recall
- Recall Reason: In extremely rare cases, the automated slide-making machine may misread the encoded value on the barcode label of the sample bottle. If a misread occurs, the misread sample bottle ID value will be transferred to the slide, which is equivalent to making a slide with an incorrect identifier.
- Discovering Company: Hologic Technologies (Beijing) Co., Ltd.
- Manufacturing Company: Hologic, Inc.
- Summary: 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.

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