—#33127

Product

IMMAGE IgM Reagent Part No.: 447610

FDA product code: DEW — Igg, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K963868
Affected lot / code info: Lots M210213, M303183

Why it was recalled

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 (FDA determination)

Other

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated: 2003-06-06
Posted by FDA: 2004-07-23
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.