FDA-Device2018-10-24Class II
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
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
2 sets
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2019Don't want to check this manually?
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