Z-1055-2012

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

Name: Z-1055-2012 ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no...
Creator: Phadia US Inc
Published: 2012-01-03
License: https://open.fda.gov/license/

Phadia AB / initiated 2012-01-03 / Terminated

FDA source

Phadia US Inc began a recall of ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in... on 2012-01-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1055-2012
Status: Terminated
Initiated: 2012-01-03
Posted: 2012-02-17
Terminated: 2013-02-04
Recalling firm: Phadia AB
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.
Product code: MVU Reagents, Specific, Analyte
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 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 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,
Product codes and lots: Article number 14-5274-10, Lot number BDZ0P

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)