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Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrati
Recalled October 24, 2018 · FDA recall Z-0114-2019 · Siemens Healthcare Diagnostics
Hazard
A potential bias was identified with certain kits compared to the internal standards. · FDA Class II
Units
69 kits
Sold at
US Nationwide Distribution
Description
A potential bias was identified with certain kits compared to the internal standards.
Product
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →