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U.S. Department of Health and Human Services

Class 2 Device Recall ImmunoCAP" Allergen c5, Ampicilloyl

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 Class 2 Device Recall ImmunoCAP" Allergen c5, Ampicilloylsee related information
Date Initiated by FirmDecember 18, 2017
Create DateApril 05, 2018
Recall Status1 Terminated 3 on March 27, 2019
Recall NumberZ-1312-2018
Recall Event ID 79444
510(K)NumberK051218 K993388 
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
ProductImmunoCAP 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.
Code Information Lots  990DS, Exp 2017.12.31 990DT, Exp 2018.01.31 990DW, Exp 2018.03.31 990DX, Exp, 2018.05.31 990DY
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information ContactMartin R. Mann
269-833-1819
Manufacturer Reason
for Recall		The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
FDA Determined
Cause 2		Device Design
ActionCustomers are being asked to please stop using all current product, and scrap any unused products. Please disregard any reported test result below the assay Limit of Quantification (LoQ 0.1 kUA/l) from the lots, as these results may not be valid. Please note that assay results above the Limit of Quantification, will only be affected by giving a lower result than the real value. Please fill in the Recall Letter Acknowledgement Form provided, including the table in the response form to obtain credit, and return the signed response by e-mail or fax.
Quantity in Commerce950 total
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DHB
510(K)s with Product Code = DHB
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