Siemens Healthcare Diagnostics, Inc. recalls IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum…

Recall date

April 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2841-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted

Why it was recalled

24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.