FDA-Device2018-10-24Class II
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Siemens Healthcare Diagnostics, Inc
Hazard
A potential bias was identified with certain kits compared to the internal standards.
Sold states
US Nationwide Distribution
Affected count
69 kits
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0114-2019Don't want to check this manually?
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