Recalls / —
—#32878
Product
IMMAGE IGMLC Reagent Part Number: 447470
- FDA product code
- CFN — Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class 2
- Medical specialty
- Immunology
- Affected lot / code info
- Lots prior to M303157
Why it was recalled
Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
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 #32878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.