FDAClass IIApril 11, 2018

ImmunoCAP Allergen c5 recall: Undeclared Allergen

ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of…

Why was ImmunoCAP Allergen c5 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of…
Recalling firm
Phadia US Inc
Quantity
950 total
Distribution
Nationwide Distribution
Recall date
April 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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