ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended us

FDA device recall Z-1055-2012 · posted 2012-02-17 · Terminated

Recall details

Recalling firm

Phadia US Inc

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).

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

MVU

Quantity affected

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,

Date initiated

2012-01-03

Date posted

2012-02-17

Date terminated

2013-02-04

Location

Portage, MI