# China NMPA Product Recall - Fully automated sample processing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/ec5d86ec-3b91-4af0-b7b3-102f014dfde1/
Source feed: China

> China NMPA product recall for Fully automated sample processing system by Ortho-Clinical Diagnostics, Inc. published April 23, 2015. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall, reported to the

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls its fully automated sample processing system.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2015-04-23
- Product Name: Fully automated sample processing system
- Recall Reason: Urine samples used with Custom or Select v3.2.2 and earlier versions; or Select v5.0 and those used with calcium assay strips (colorimetric method), magnesium assay strips (colorimetric method), or phosphorus assay strips (colorimetric method) require acidification (pretreatment). However, the current enGen system software does not route these samples to the "Manual Priority Processing" exit position for pretreatment as intended. Furthermore, the enGen system software currently allows setting invalid test combinations. Invalid test combinations refer to urine samples that simultaneously contain different pretreatment requirements, i.e., acidification, alkalization, or extraction treatments performed before processing on the VITROS analyzer, or urine samples that do not require treatment. If an invalid test combination is set, the sample will be sent to the "Invalid Priority Processing" exit position according to the set route, and the test will need to be reset individually or set to a valid test combination.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary recall, reported to the National Medical Products Administration (NMPA) on April 23, 2015, concerning a Fully Automated Sample Processing System, model TCAutomation. Manufactured by Ortho-Clinical Diagnostics, Inc., the recall addresses a critical software defect affecting versions v3.2.2 and earlier, and v5.0. The primary issues include the system's failure to correctly route urine samples requiring acidification for specific tests (calcium, magnesium, phosphorus) to a "Manual Priority Processing" exit for necessary pretreatment. Additionally, the software permits the creation of "invalid test combinations," where urine samples with conflicting pretreatment requirements (e.g., acidification and alkalization) are processed incorrectly, leading to samples being directed to an "invalid priority processing" exit. Operating under the NMPA's regulatory framework for imported medical devices (Permit No. 20131404786), Johnson & Johnson reported that only one unit of the affected system was imported into China. This single unit was exclusively used for internal training purposes at Johnson & Johnson Academic Centers and was never sold or distributed into the commercial market. Consequently, beyond the initial report to the NMPA, the company stated no further recall actions, investigation, evaluation reports, or implementation plans would be undertaken in China, given the product's contained use and absence from public circulation.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/