Аналіз інформації за період 01.07.2016 – 31.07.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризик

Великобританія

https://www.gov.uk/drug–device–alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

·         ghtSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette – devices may give incorrect results that could lead to a missed diagnosis.

Manufactured by Hangzhou Biotest Biotech Co Ltd: certain lots of these devices may give an incorrect false negative or false positive result when testing for HIV, HCV and HBV. These are point of care tests intended for use ONLY in professional clinical settings.

Alert type: Medical device alert Issued: 26 July 2016

·         Medical device alerts archived in July 2016

A list of all medical device alerts that were archived in July 2016.

Alert type: Medical device alert Issued: 25 July 2016