Recalls / —
—#40328
Product
DL 2000 Data Manager
- FDA product code
- JQP — Calculator/Data Processing Module, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Not Applicable but refers to software version 6.4.109f
Why it was recalled
Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
Root cause (FDA determination)
Other
Action the firm took
Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2005-06-20
- Posted by FDA
- 2005-08-16
- Terminated
- 2011-10-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #40328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.