FDA-Device2020-07-01Class II
Atellica CH Chemistry Calibrator
Siemens Healthcare Diagnostics, Inc.
Hazard
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Sold states
US Nationwide Distribution
Affected count
1522 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Chemistry Calibrator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2431-2020Don't want to check this manually?
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