The Recall Desk

FDA (Devices) recall action 79444

Phadia US Inc recalled 2 products on 2018-04-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-04-11
Critical
0
Units
1,900

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2018-04-11

    Phadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures

    Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.

    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 500
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-04-11

    Phadia Recalls ImmunoCAP Allergen c5 Ampicilloyl Test Kits

    Phadia US Inc is recalling ImmunoCAP Allergen c5, Ampicilloyl test kits because stability specifications were not met.

    Product
    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.
    Category
    Distribution
    0 states