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Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determin
Recalled June 12, 2013 · FDA recall Z-1512-2013 · Siemens Healthcare Diagnostics
Hazard
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability · FDA Class II
Units
309 (100 test) kits
Sold at
Nationwide Distribution.
Description
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Product
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. 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 →