Multiple IVD Products Subject to Urgent Recalls by Illumina, Ortho-Clinical Diagnostics, and Abbott
Illumina
Diagnostic Product Developer
On May 22, the National Medical Products Administration issued a batch of recall notices. Among them, there are 3 IVD products, fromIllumina, Ortho Clinical Diagnostics, Abbott.
Illumina (China) Scientific Co., Ltd. reported that due toA network security vulnerability was discovered, which may lead to the inability of instrument analysis to generate correct results or pose a potential risk to data security.Illumina, Inc. voluntarily recalls gene sequencers (China Medical Device Registration No. 20183400291). The recall is classified as a Level II recall. Detailed information regarding the models, specifications, and batches of the affected products can be found in the "Medical Device Recall Event Report."
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Abbott Trading (Shanghai) Co., Ltd. reported that due toUsed the wrong registration markAbbott Ireland Diagnostics Division voluntarily recalls pre-excitation solution (Record No. 20210177). The recall is classified as a Level III recall. For detailed information regarding the models, specifications, and batches of the affected products, please refer to the "Medical Device Recall Report."
(Pre-excitation solution is used in conjunction with a fully automatic immunoassay analyzer to provide a reaction environment for chemiluminescence reactions.)
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Ortho Clinical Diagnostics Trading (China) Co., Ltd. reported that due toA specific batch may lead to a bias in the upper limit of the reportable range.Ortho-Clinical Diagnostics, Inc., a U.S.-based manufacturer, has voluntarily recalled the VITROS Chemistry Products Calibrator Kit 20 (Registration No. 20172400280) for special protein calibrators. The recall is classified as a Level 2 recall. Detailed information regarding the models, specifications, and batches of the affected products can be found in the Medical Device Recall Report.
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Source: National Medical Products Administration, Experimental Medicine
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