Recalls / —
—#33098
Product
Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.
- FDA product code
- JIS — Calibrator, Primary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- All lots.
Why it was recalled
Sample values may be decreased by between 9 and 12 percent.
Root cause (FDA determination)
Other
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
Timeline
- Recall initiated
- 2003-09-17
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #33098. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.