The Recall Desk
ModerateFDA (Devices)·Z-1313-2018·Announced 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.

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, but 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, fitting the criteria for a moderate severity score.

Plain-English summary

Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl (Article number 14-4451-016). The 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 of the ImmunoCAP Allergen c6, Amoxicilloyl were not met. The affected lots are 991DA (exp. 2018.04.30), 991DC (exp. 2018.07.31), 991D7, and 991D9 (exp. 2018.02.28). The product was distributed nationwide.

Healthcare facilities and laboratories should stop using the affected product and contact Phadia US Inc for further instructions. Consumers should not use the product if they have it in their possession.

The recalled product

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
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 (4)

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

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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