Siemens Healthcare Diagnostics, Inc recalls IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vi…
- Recall date
- January 4, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1420-2017
- 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/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems 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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