Medical device recalls Moderate risk

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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