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Terminated

IMMAGE IGALC Reagent Part Number: 447460

FDA Recall Z-1146-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeCFN
Date Initiated2003-06-06
Date Terminated2004-08-30

Reason for Recall

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993547BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREBBeckman Coulter, Inc. · 2000-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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