Recall Z-1150-04 ยท DEW Igg, Antigen, Antiserum, Control
Beckman Coulter Inc
IMMAGE IgM Reagent Part No.: 447610
| Date | Jul 23, 2004 (initiated Jun 6, 2003) |
| Status | Terminated |
| Reason | low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66. |
| Root cause | Other |
| Quantity | 10,000 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963868 | IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) Beckman Instruments, Inc., Feb 10, 1997 |