ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00488-1

Class II

2017-04-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00488-1

An internal investigation by siemens has identified that certain lots of the advia centaur systems insulin (iri) assay recover approximately 40% higher than the world health organisation (who) 1st irp 66/304 standardisation based on slope values. the slope value was observed to be 1.40 on the advia centaur xp and 1.42 on the advia centaur cp. the potential exists for misinterpretation of insulin levels when comparing to the who standard. siemens has confirmed that the assay’s reportable range, reference interval, precision, analytical sensitivity, hook effect and linearity are not impacted by this issue and continue to meet the assay performance characteristics as stated in the instructions for use.

Siemens is advising users that standardisation to WHO 1st IRP 66/304 has been restored beginning with ADVIA Centaur IRI ReadyPack kit lots ending in 201 and IRI Calibrator kit lots ending in 02, which will be available by May 2017. In the interim, users can continue to use existing product to report results and should ensure that clinicians are made aware that results will be approximately 40% higher than the WHO 1st IRP 66/304 material. Upon receipt of ADVIA Centaur Systems Insulin ReadyPack kit lots ending in 201 (and future lots) and IRI Calibrator kit lots ending in 02 (and future lots), users are discontinue use of the affected product. The Bio-Rad website should be referred to for revised control targets and ranges to be used with corrected product. For all other commercially available controls, evaluate the need for target reset. Further details regarding expected performance are detailed in the customer letter.