Phadia US Inc: Medical Device Recall in 2018 - (Recall #: Z-1313-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 18, 2017

Date Posted: April 11, 2018

Recall Number: Z-1313-2018

Event ID: 79444

Reason for Recall:

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

Status: Terminated

Product Quantity: 950 total

Code Information:

Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated