Siemens Healthcare Diagnostics, Inc recalls IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: F…
- Recall date
- January 4, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1421-2017
- 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
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
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