Recall Z-1044-2009 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Immuno Concepts Inc
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
| Date | Apr 6, 2009 (initiated Dec 4, 2008) |
| Status | Terminated |
| Reason | Samples can occasionally run out of the wells and cross contaminate adjacent wells. |
| 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 | 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. |
| FDA record | Open on fda.gov |