Z-1044-2009

ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog...

Name: Z-1044-2009 ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog...
Creator: Immuno Concepts Inc
Published: 2008-12-04
License: https://open.fda.gov/license/

IMMUNO CONCEPTS, NA, Ltd. / initiated 2008-12-04 / Terminated / root cause: manufacturing process

FDA source

Immuno Concepts Inc began a recall of ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200... on 2008-12-04. The reason FDA records is "Samples can occasionally run out of the wells and cross contaminate adjacent wells". 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-1044-2009
Status: Terminated
Initiated: 2008-12-04
Posted: 2009-04-06
Terminated: 2009-11-10
Recalling firm: IMMUNO CONCEPTS, NA, Ltd.
Product: ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: Samples can occasionally run out of the wells and cross contaminate adjacent wells.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified customers via a "Notice of Market Withdrawal" letter, e-mail and telephone. The letter described the problem and instructed customers to removed affected product from their inventory, complete the attached form and return it via fax to Immuno Concepts, Inc. at 916-363-2843. The firm will issue replacements as requested. Direct questions to Immuno Concepts, Inc. at 916-363-2649.
Quantity in commerce: 378 kits
Distribution: Worldwide Distribution, USA (NC, WI, MS, MD, IL, GA, CA, MI and Puerto Rico) and countries of Sweden, Mexico, Spain and Denmark.
Product codes and lots: Sub Assembly Lot Numbers: 0823200, 0823201, and 0825500 and Kit Lot Numbers: 826305, 0827311, 0828107, 0828108, 0828109, 0830914, 0831607, 0831606, 0829719, 0827315, 0827301, 0829413, 0829512, 0826905, 0828114, 0828804, 0829414, 0829721, 0830300, 0828307 and 0829513.

Product code DHN

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)