Alerta De Seguridad para One Step HCG Pregnancy Test

Safety alert

2016-01-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160114b.html

Press release: recall of two batches of one step hcg pregnancy test the department of health (dh) today (january 14) drew public attention to the recall by the therapeutic goods administration (tga) of australia concerning the one step human chorionic gonadotropin (hcg) pregnancy test (batch numbers: 20150314 and 20140406) manufactured by blue cross bio-medical (beijing) co ltd, as they may give false negative results. the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the tga of australia. according to the alert, there were complaints lodged by the users about false negative results of the product. results of subsequent testing undertaken by the tga have shown that these two batches do not comply with the claim in the instructions for use, which specify that "in less than 5 minutes, levels of hcg as low as 25miu/ml can be detected." batch 20150314 has failed to detect hcg in human urine at concentrations of 10, 25 and 50miu/ml levels while batch 20140406 has failed at hcg concentrations of 10, 25, 50 and 100miu/ml. a spokesman for the dh explained that false negative results in the worst case can result in misdiagnosis and significant harm. "although preliminary enquiry with the manufacturer reveals no evidence of the affected product having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the product from abroad or from internet purchase. the public is advised to stop using the concerned batches of the product and seek the advice of healthcare professionals if in doubt," the spokesman said. so far, the dh has not received any local report of adverse incidents arising from use of the product. ends/thursday, january 14, 2016issued at hkt 19:57.