ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 200
FDA device recall Z-1044-2009 · posted 2009-04-06 · Terminated
Recall details
- Recalling firm
- Immuno Concepts Inc
- Reason for recall
- Samples can occasionally run out of the wells and cross contaminate adjacent wells.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DHN
- Quantity affected
- 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.
- Date initiated
- 2008-12-04
- Date posted
- 2009-04-06
- Date terminated
- 2009-11-10
- Location
- Sacramento, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENZYME ANA TEST SYSTEM (K833148) | Immuno Concepts, Inc. | 1983-11-21 |
| ANA-IFA TEST SYSTEM (K803276) | Immuno Concepts, Inc. | 1981-01-26 |