FDA-Device2018-04-11Class II
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.
Phadia US Inc
Hazard
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
Sold states
Nationwide Distribution
Affected count
950 total
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief