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U.S. Department of Health and Human Services

Class 3 Device Recall ImmunoCAP Allergen Ri206

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  Class 3 Device Recall ImmunoCAP Allergen Ri206 see related information
Date Initiated by Firm January 03, 2012
Date Posted February 17, 2012
Recall Status1 Terminated 3 on February 04, 2013
Recall Number Z-1055-2012
Recall Event ID 60513
Product Classification Reagent, specific, analyte - Product Code MVU
Product ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana

It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.
Code Information Article number 14-5274-10, Lot number BDZ0P
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information Contact Martin R. Mann
269-492-1957
Manufacturer Reason
for Recall		 The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o .1 kUA/L).
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action ThermoFisher sent an URGENT RECALL NOTIFICATION letter dated December 22, 2011, to all affected consignees. The letter identifed the product, the problem, and the action to be taken by the conignee. Consignees were recommended to cease testing on the affected lot of product and, if so desired, substitute with ImmunoCAP Allergen i6, German Cockroach, until ImmunoCAP Allergen Ri206 was in stock. For any questions regarding this notification, contact Technical Support at 800.346.4364, option 2.
Quantity in Commerce 780; all sent to US, with 10 assays per sleeve
Distribution Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
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.
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