RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A.
FDA device recall Z-1045-2009 · posted 2009-04-06 · Terminated
Recall details
- Recalling firm
- Immuno Concepts Inc
- Reason for recall
- In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
- Action taken
- The firm has issued telephone calls, e-mails and notification letters to its consignees.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LLL
- Quantity affected
- 25 kits
- Distribution
- Worldwide Distribution including USA, Australia, England, Sweden and Austria.
- Date initiated
- 2008-11-25
- Date posted
- 2009-04-06
- Date terminated
- 2009-11-17
- 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 |
|---|---|---|
| RELISA ENA ANTIBODY SCREENING TEST SYSTEM (K935129) | Immuno Concepts, Inc. | 1994-01-31 |