Recall Z-1055-2012 ยท MVU Reagents, Specific, Analyte
Phadia US Inc
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.
| Date | Feb 17, 2012 (initiated Jan 3, 2012) |
| Status | Terminated |
| Reason | 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). |
| Root cause | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.