Recalls / —
—#32615
Product
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
- FDA product code
- JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K023764
- Affected lot / code info
- All software versions pior to version 1.4
Why it was recalled
Software coding error may cause a fatal error message.
Root cause (FDA determination)
Other
Action the firm took
Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2004-03-29
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-09-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #32615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.