Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ImmunoCAP Allergen c5 Recalled by Phadia US Inc Due to The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl...

Date: December 18, 2017
Company: Phadia US Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Phadia US Inc directly.

Affected Products

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.

Quantity: 950 total

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Phadia US Inc

Phadia US Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report