FDA-Device2013-06-12Class II
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Siemens Healthcare Diagnostics, Inc
Hazard
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Sold states
Nationwide Distribution.
Affected count
309 (100 test) kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2013Don't want to check this manually?
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