FDA-Device2013-06-12Class II

ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

Siemens Healthcare Diagnostics, Inc
Hazard

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Sold states
Nationwide Distribution.
Affected count
198 (6 pk)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1515-2013

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