Clongene Biotech CLUNGENE hCG Pregnancy Test 의 안전성 경고

Safety alert

2014-09-30

2014-09-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930b.html

Medical device safety alert: hangzhou clongene biotech clungene hcg pregnancy test the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning clungene hcg pregnancy test, manufactured by hangzhou clongene biotech co., ltd. with the following details: lot no.: 13122001 and 14060301 types: strip, cassette and midstream the clungene hcg pregnancy test midstream (lot 13122001 and 14060301) gave 17 false positive results at 5 ireland healthcare facilities from 12th june 2014 to 7th august 2014. the manufacturer tested the reserved samples of lot13122001, lot14060301 in the factory and returned 20pcs sticks from distributor, and all test results are passed. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.