Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Calibrator
Recalled July 1, 2020 · FDA recall Z-2430-2020 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
1872 units
Sold at
US Nationwide Distribution
Description
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.
Product
ADVIA Chemistry Calibrator
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →