K-Tips 에 대한 현장 안전성 서한

Field Safety Notice

2009-11-05

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/k-tips---important-safety-information-from-roche-diagnostics-gmbh&id=12d1f825-9782-6eee-9b55-ff00008c97d0

Background information or related documents: roche has confirmed a problem with k-tips (m/n: 03287343001), lots 09001108, 09002108, 09003108, 09004108, 09005108, 09006108, 09007108, 09008108 and 09009108, which are for use with the cobas® ampliprep instrument. the affected lots contain k-tips that are completely closed (near the pipetting end of the k-tip), which prevents the cobas® ampliprep instrument from pipetting eluate from the spu into the k-tube. roche has confirmed that use of these defective k-tips will result in an invalid run and no reportable results. roche is recalling all affected lots. further information is available in the field safety notice below. important safety information - k tips note: field safety notices are placed on our website for information purposes. you will not normally need to take further action unless the manufacturer has contacted you directly or we have issued additional advice.