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Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the qu
Recalled June 12, 2013 · FDA recall Z-1513-2013 · Siemens Healthcare Diagnostics
Hazard
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability · FDA Class II
Units
3302 Kits (500 test)
Sold at
Nationwide Distribution.
Description
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →