PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Pro…

Recall date

January 10, 2019

Source

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

Recall number

Z-1239-2019

FDA classification

Class II

Brand / firm

PerkinElmer Life and Analytical Sciences, Wallac, OY

Sold / distributed

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

Why it was recalled

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

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

What was recalled

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).