Recalls / —
—#66549
Product
Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834
- FDA product code
- GKZ — Counter, Differential Cell
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K071681
- Affected lot / code info
- Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144, AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100, AK24164, AJ47338, AJ13070, AL06029, AJ13071, AK32212, AK32210, AJ39264, AJ43304
Why it was recalled
Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
Root cause (FDA determination)
Software design
Action the firm took
Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Worldwide Distribution- USA and country of Canada.
Timeline
- Recall initiated
- 2007-06-29
- Posted by FDA
- 2008-04-30
- Terminated
- 2012-12-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.