The Recall Desk
ModerateFDA (Devices)·Z-1312-2018·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a failure to meet stability specifications, which is a quality control issue without reported adverse health consequences.

Plain-English summary

Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). This product is an in vitro quantitative assay used to measure allergen-specific IgE in human serum or plasma. It is intended for use with Phadia 250, Phadia 1000, Phadia 2500, and Phadia 5000 instruments.

The recall was initiated because the stability specifications for the product were not met. The affected lots are 990DS (Exp 2017.12.31), 990DT (Exp 2018.01.31), 990DW (Exp 2018.03.31), 990DX (Exp 2018.05.31), and 990DY. The products were distributed nationwide.

Healthcare facilities and laboratories should stop using the affected products and contact Phadia US Inc for further instructions. Consumers should not use these test kits at home, as they are intended for professional laboratory use.

The recalled product

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.
Manufacturer
Phadia US Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
950

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Phadia US Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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