Recall Z-1146-04 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Beckman Coulter Inc
IMMAGE IGALC Reagent Part Number: 447460
| Date | Jul 23, 2004 (initiated Jun 6, 2003) |
| Status | Terminated |
| Reason | Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid). |
| Root cause | Other |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993547 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB Beckman Coulter, Inc., Feb 1, 2000 |