Etest Ertapenem 의 안전성 경고

Safety alert

2014-02-12

2014-02-12

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140212.html

Medical device safety alert: biomerieux etest ertapenem medical device manufacturer, biomerieux, has issued a field safety notice concerning certain lots of the following products: etest ertapenem - foam etp 32 – 30 tests (reference: 531610); etest ertapenem- foam etp 32 – 100 tests (reference: 531618); etest ertapenem etp 32 – single pack of 30 tests (reference: 412332) the manufacturer identified a performance issue on the etest foam ertapenem (reference 531610 and 531618) and etest single pack ertapenem (reference 412332). these strips did not give the correct minimum inhibitory concentration (mic) for some of quality control strains. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. the manufacturer advises users to discontinue using and to destroy the affected kits. it will provide replacement kits as soon as a new batch of etest ertapenem is available. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 12 february 2014.