Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro di…
- Recall date
- January 4, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1418-2017
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc
- Sold / distributed
- US Nationwide distribution including Puerto Rico
Why it was recalled
DHEA-S causes falsely elevated progesterone results.
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 Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
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