EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00389-1

Class II

2016-04-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00389-1

Siemens has identified an issue with use of the ezee-nest insert cups due to 2 inaccuracies that exist in the advia centaur cp operator’s guide, appendix d, pre-set tube types. the 1st inaccuracy refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50ul can be used; however volumes greater than 150ul cannot be used when using an ezee-nest insert cup. the 2nd inaccuracy refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. there is no impact on patient samples as a result of these issues. there is the potential for loss of aspirated sample (up to 250 ìl including the dead volume in the insert cup) & a delay in providing patient test results due to this issue.

Siemens is advising users to not use EZee-Nest Insert Cups with assays that require sample volumes greater than 150µL or the Universal Cup Adapter with the EZnee-Nest insert cups in 65mm sample racks. Users should instead use the Siemens Sample cup along with the required 100mm sample rack and 100mm Siemens cup Tube Setting for assays that require sample volumes larger than 150µL.