Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Recall date
- December 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1231-2020
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- US Nationwide
Why it was recalled
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
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 Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
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