Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01243-1

Class II

2016-09-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01243-1

Siemens healthcare diagnostics has identified that affected lots may produce depressed results with current lots of calcium reagent. although the affected lots are expired, the calcium calibration interval is 90 days; therefore, it is possible that calibrations using the affected calibrator lots are active. average bias for current calcium (ca) reagent lots ranges from -0.08 mmol/l to -0.2 mmol/l with a maximum individual sample bias of -0.3 mmol/l. biases were calculated based on the differences observed when comparing to results generated using nist standard material for calibration. biases were similar for urine and serum samples and were not dependent upon calcium concentration. when this issue occurs, the potential exists for misinterpretation of calcium levels, which may affect consideration of intervention.

Siemens is advising user that if they have an active calibration of Calcium (CA) that used calibrator lot 5GM081 or 5GM082, recalibrate CA with an alternate lot of CHEM 1 CAL. Siemens is not recommending a review of previously generated results.