FDA recall Z-1313-2018

Product

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.

Reason for recall

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

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-12-18

Report date

2018-04-11

Termination date

2019-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2018