FDA-Device2013-06-12Class II
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).
Siemens Healthcare Diagnostics, Inc
Hazard
iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Sold states
Nationwide Distribution.
Affected count
3302 Kits (500 test)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief