Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2 에 대한 현장 안전성 서한

Field Safety Notice

2017-12-12

2017-12-29

Serbia

ALIMSA

https://www.alims.gov.rs/latin/2017/12/29/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-monoclonal-mouse-anti-human-cdx2-clone-dak-cdx2-histologija-citoloski-reagens/

The certificate of analysis ("coa") and the inner pack of "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) contain an error in the protein concentration value of 292.7 mg / l, which is sixteen times greater than the correct concentration. which is 18.3 mg / l. the "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) medical device will perform its function according to the manufacturer's intention, that is, this error does not affect the quality, performance or effectiveness of the medical device. therefore, there is no change in the concentration itself, and the outer packaging indicates the correct concentration of 18.3 mg / l. if the product is diluted with an inaccurate concentration greater than 292.7 mg / l, a diminished color strength will be seen, resulting in poor or negative coloration. this should be easy to detect both in internal positive normal tissue and in recommended positive external process controls. to date, the manufacturer has received only one complaint from the user, who noticed this during testing, and no adverse effects have been reported on any patient.