Recalls / —
—#33131
Product
Synchron Systems Lipid Calibrator (HDLD) Part 650218
- FDA product code
- JIS — Calibrator, Primary
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K983640
- Affected lot / code info
- Kit; M302210 Level 1; M302211 Level 2; M302212
Why it was recalled
Incorrect units are printed in labeling but not in software.
Root cause (FDA determination)
Other
Action the firm took
Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2003-10-03
- Posted by FDA
- 2004-07-23
- Terminated
- 2004-08-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #33131. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.