Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Chemistry Calibrator

Recall date
June 5, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2431-2020
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atellica CH Chemistry Calibrator

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