ClearanceBrief
Recall Z-1147-04 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)

Beckman Coulter Inc

IMMAGE IGMLC Reagent Part Number: 447470

DateJul 23, 2004 (initiated Jun 6, 2003)
StatusTerminated
ReasonInconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
Root causeOther
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.