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.
This recall has been terminated (originally issued February 17, 2012).
- Company
- Phadia Us Inc
- Recall Initiated
- January 3, 2012
- Posted
- February 17, 2012
- Terminated
- February 4, 2013
- Recall Number
- Z-1055-2012
- Quantity
- 780; all sent to US, with 10 assays per sleeve
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
Lot / Code Info
Article number 14-5274-10, Lot number BDZ0P
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
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.