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.
This recall has been terminated (originally issued April 6, 2009).
- Company
- Immuno Concepts Inc
- Recall Initiated
- December 4, 2008
- Posted
- April 6, 2009
- Terminated
- November 10, 2009
- Recall Number
- Z-1044-2009
- Quantity
- 378 kits
- Firm Location
- Sacramento, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Samples can occasionally run out of the wells and cross contaminate adjacent wells.
Distribution
Worldwide Distribution, USA (NC, WI, MS, MD, IL, GA, CA, MI and Puerto Rico) and countries of Sweden, Mexico, Spain and Denmark.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.