Phadia US Inc: Medical Device Recall in 2018 - (Recall #: Z-1312-2018)

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 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.

Product Classification:

Class II

Date Initiated: December 18, 2017

Date Posted: April 11, 2018

Recall Number: Z-1312-2018

Event ID: 79444

Reason for Recall:

The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

Status: Terminated

Product Quantity: 950 total

Code Information:

Lots 990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated