ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01056-1

Class II

2016-08-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01056-1

Siemens healthcare diagnostics has confirmed that the advia centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the advia centaur myoglobin instructions for use (ifu), for all in-date reagent lots when evaluated with calibrator u kit lots ending in 63 and 64. values up to 12 ng/ml (ug/l) were observed.Siemens’ investigation has identified that certain calibrator u kit lots have drifted from the internal standardisation causing a positive shift in results. analytical sensitivity and alignment to the internal standardisation will be restored with the release of calibrator u kit lots ending in 65 (cu65) and higher. customers will observe a negative shift in quality control (qc) material and patient results when transitioning to cu65. as a result, revised qc targets and ranges for bio-rad controls have been established and published on the bio-rad website at qcnet.Com.

Siemens is advising that customers may continue to use Calibrator U lots CU63 and CU64 with any in-date reagent kit lot and current QC ranges. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the laboratory. Update 7 October 2016: Siemens are advising that Calibrator kit lot CU65 is now avaliable. The use of lots CU63 and CU63 should be discontinued and the lots discarded.