# China NMPA Product Recall - Vancomycin Assay Kit (Immunochemical Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/fd57606c-2706-4b73-bdb6-b07f3fecc6cf/
Source feed: China

> China NMPA product recall for Vancomycin Assay Kit (Immunochemical Method) by Ortho-Clinical Diagnostics, Inc. published June 20, 2012. Recall level: . The National Medical Products Administration (NMPA) issued a notice (Index No. JGXX-2012-10070) on J

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. is recalling its vancomycin assay kit (immunoassay).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2012-06-20
- Product Name: Vancomycin Assay Kit (Immunochemical Method)
- Recall Reason: When a vancomycin assay kit (immunoassay) is loaded with both 19th or 20th generation and 21st or higher generation reagents simultaneously on VITROS® 5.1 FS Automated Biochemical Analyzer software version 2.6.1 or earlier, or VITROS® 5600 Automated Biochemical Immunoassay Analyzer software version 2.0 or earlier, the system may unexpectedly switch to and use the previous batch of reagents on the system reagent plate for quality control tests. If the operator does not notice the 'PV2-097' condition code indicating an unexpected batch switch, calibration results may be deviated.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice (Index No. JGXX-2012-10070) on June 20, 2012, concerning a voluntary product recall by Ortho-Clinical Diagnostics, Inc. The recall involves certain models of their vancomycin assay kits (immunoassay) due to potential calibration deviations. The core issue arises when different generations of these kits are simultaneously loaded onto specific VITROS® 5,1 FS or VITROS® 5600 automated analyzers running older software versions. Under these conditions, the system might unexpectedly switch to and utilize a previous batch of reagents for quality control, potentially leading to inaccurate calibration if a specific condition code ('PV2-097') is overlooked by the operator. Ortho-Clinical Diagnostics, Inc., facilitated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., confirmed that this global recall does not impact the Chinese market. All affected kits were reported to be expired, meaning no products within China required active recall measures. As a result, China will not issue a separate recall implementation report. The NMPA instructed provincial and municipal food and drug administrations to reinforce their supervision of similar medical products.

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