U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Reagent, specific, analyte - Product Code MVU
원인
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).
조치
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.
Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
제품 설명
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.