Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP, Centaur XPT Systems. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00092-1

Class II

2017-01-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00092-1

Siemens healthcare diagnostics has confirmed a negative bias for the advia centaur ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems. upon internal investigations siemens observed an average bias, when compared to calibrator a lots ending in 89, of -11% (range -28 to 7%) for ft4 dose of < 0.89ng/dl (<11.5pmol/l), -5% (range -14 to 0%) for 0.89ng/dl to 1.76ng/dl (11.5 to 22.7pmol/l) and -7% (range -16 to 3%) for >1.76ng/dl (>22.7pmol/l). when this issue occurs, the potential exists for misinterpretation of ft4 values as below the reference interval listed in the ifu when truly normal. in addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected.

Siemens is advising Advia Centuar FT4 assay customers using the Advia Centaur, Centaur XP, Centaur XPT Systems to discontinue use of and discard the affected Calibrator A kit lots ending in 90, and to use Calibrator A kit lots ending in 91 to calibrate the FT4 assay on these Systems. Siemens will replace affected stock. The information provided in the customer letter is to be reviewed by the Medical Director, with a review of previously generated results at the discretion of the laboratory. Advia Centaur FT4 assay customers using the Advia Centaur CP System can continue to use all available Calibrator A lots including those ending in 90.