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U.S. Department of Health and Human Services

Class 2 Device Recall ImmunoCAP Allergen c6, Amoxicilloyl

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  Class 2 Device Recall ImmunoCAP Allergen c6, Amoxicilloyl see related information
Date Initiated by Firm December 18, 2017
Create Date April 05, 2018
Recall Status1 Terminated 3 on March 27, 2019
Recall Number Z-1313-2018
Recall Event ID 79444
510(K)Number K993388  K051218  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
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 5000.
Code Information Lots  991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information Contact Martin R. Mann
269-833-1819
Manufacturer Reason
for Recall		 The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
FDA Determined
Cause 2		 Device Design
Action Customers 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 Commerce 950 total
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DHB and Original Applicant = PHARMACIA & UPJOHN CO.
510(K)s with Product Code = DHB and Original Applicant = PHARMACIA DIAGNOSTICS AB
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