ImmunoCAP Allergen c6 recalled over undeclared allergens

Recall date

December 18, 2017

Source

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

Official notice title

Phadia US Inc recalls ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative a…

Recall number

Z-1313-2018

FDA classification

Class II

Brand / firm

Phadia US Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

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

What was recalled

ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.