# China NMPA Product Recall - tissue processing machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-shandon-limited-trading-as-thermo-fisher-scientific/ef2a814e-1891-4888-b67d-a24f7e023ceb/
Source feed: China

> China NMPA product recall for tissue processing machine by Thermo Shandon Limited trading as Thermo Fisher Scientific published April 21, 2016. Recall level: Level III. Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its Excelsior A

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Thermo Fisher Scientific (China) Co., Ltd. voluntarily recalls tissue processors
- Company Name: Thermo Shandon Limited trading as Thermo Fisher Scientific
- Publication Date: 2016-04-21
- Product Name: tissue processing machine
- Recall Level: Level III
- Recall Reason: 248.5513 days after the product was powered on, a software error occurred that switched from a positive counting cycle to a negative counting cycle. This caused the rotary valve in the Excelsior AS tissue processor to stop moving at any point in the tissue processing cycle, potentially resulting in poor sample processing.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Thermo Shandon Limited trading as Thermo Fisher Scientific
- Summary: Thermo Fisher Scientific (China) Co., Ltd. initiated a voluntary Class III recall of its Excelsior AS Tissue Processor, reported to the National Medical Products Administration (NMPA) on March 3, 2016. The recall stems from a discovered software error where, approximately 248 days after initial power-on, the device's internal counting cycle could invert from positive to negative. This critical flaw causes the rotary valve to cease movement mid-cycle, potentially leading to inadequate pathological sample processing. While the issue triggers audible and visual alarms, and poor processing results can be detected in subsequent laboratory steps, it primarily causes inconvenience and short-term delays in clinical diagnostics, without posing a direct risk of misdiagnosis or patient harm. Thermo Fisher Scientific has outlined immediate and long-term corrective actions. Temporarily, operators can restart affected devices using a 10-step procedure upon an alarm. The definitive solution involves a software upgrade to version 2548 - Issue 16, which the company's after-sales service engineers are proactively installing on-site for all 82 affected units distributed in China. This proactive measure ensures product safety and reliability.

Company: https://www.globalkeysolutions.net/companies/thermo-shandon-limited-trading-as-thermo-fisher-scientific/51c490e4-b37c-44fc-8b6a-0a45cc11de2e/