Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur…
- Recall date
- July 24, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0113-2019
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
A potential bias was identified with certain kits compared to the internal standards.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
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