Recalls / —
—#32879
Product
Synchron Systems Prealbumin Reagent Part Number: 475106
- FDA product code
- JIS — Calibrator, Primary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Lot M210125 Exp 30 Nov 04
Why it was recalled
Instability leading to falsely elevated patient results, out of range controls, or error code.
Root cause (FDA determination)
Other
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
Timeline
- Recall initiated
- 2003-05-20
- Posted by FDA
- 2004-07-23
- Terminated
- 2004-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #32879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.