Recall Z-1045-2009 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
Immuno Concepts Inc
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
| Date | Apr 6, 2009 (initiated Nov 25, 2008) |
| Status | Terminated |
| Reason | In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive. |
| Root cause | Process control |
| Action | The firm has issued telephone calls, e-mails and notification letters to its consignees. |
| Quantity | 25 kits |
| Distribution | Worldwide Distribution including USA, Australia, England, Sweden and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935129 | RELISA ENA ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc., Jan 31, 1994 |