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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