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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Chemistry Calibrator

Recalled July 1, 2020 · FDA recall Z-2431-2020 · 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
1522 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
Atellica CH Chemistry Calibrator
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Chemistry Calibrator | RecallWatchUSA