High-end medical equipment domestic VS imports do not choose the wrong!

On July 12th, the Anhui Food and Drug Administration official website released information on the recall of medical device products produced by three companies including Synthes GmbH of Switzerland. Imports may not be better than domestic production.

Trauma Surgery Kit Biosafety Assessment "Not Close"

On the website of the Anhui Food and Drug Administration, the Swiss Synthes GmbH recalled the trauma surgical instrument kit (record number: National Machinery No. 20150914) and found that the affected products failed to pass the biosafety assessment under specific experimental conditions. .

Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. reported that the high growth inhibition levels observed during the test may be due to corrosion of the solder joints of the instrument. If the device is corroded during use, the patient may briefly come into contact with a substance that may be cytotoxic, which may eventually lead to adverse tissue reactions and delays in surgery. Its manufacturer, Synthes GmbH, voluntarily recalls the product.

Electrode box for blood gas, electrolyte and biochemical analyzer "affected"

Roche Diagnostics (Shanghai) Co., Ltd. reports that the company's blood gas, electrolyte and biochemical analyzer electrode box (Registration No.: National Food and Drug Administration (in) word 2014 No. 2403271), due to the detection of whole blood samples The Na+ concentration is affected by the partial pressure of CO2, and its manufacturer Roche Diagnostics GmbH actively recalls the product.

"Corrosion or corrosion" in the bone dynamic system

Stryker (Beijing) Medical Devices Co., Ltd. reported that the company's bone dynamic system (Registration No.: National Food and Drug Administration (Jin) No. 2012 No. 2104407), due to rust or corrosion of the grinding head, Producer Stryker Instruments voluntarily recalls the product.

All of the above three companies claimed that the recalled products were not sold in China. The State Food and Drug Administration has requested the food and drug supervision authorities of all provinces, autonomous regions and municipalities directly under the Central Government to strengthen the supervision and management of the above products.

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