ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an i...
FDA Recall #Z-1312-2018 — Class II — December 18, 2017
Product Description
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). 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.
Reason for Recall
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Recalling Firm
Phadia US Inc — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
950 total
Distribution
Nationwide Distribution
Code Information
Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated