Z-0182-2013Class III

West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that...

Name: Z-0182-2013 West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that...
Creator: Focus Diagnostics Inc
Published: 2012-10-03
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2012-10-03 / Terminated / root cause: manufacturing process

FDA source

Focus Diagnostics Inc began a recall of West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells... on 2012-10-03. FDA classified it as Class III and gives the reason as "The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0182-2013
Classification: Class III
Status: Terminated
Initiated: 2012-10-03
Posted: 2012-10-31
Terminated: 2012-12-04
Recalling firm: DiaSorin Molecular LLC
Product: West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Product code: NOP Elisa, Antibody, West Nile Virus
Reason for recall: The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900.
Quantity in commerce: 425 units
Distribution: Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
Product codes and lots: Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0182-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0182-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-31

Product code NOP

K031953Class IIWest Nile Virus Elisa Igg, Model El0300gFocus Technologies, Inc. / cleared 2003-10-22

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)