FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexibl
FDA device recall Z-1525-2008 · posted 2008-08-16 · Terminated
Recall details
- Recalling firm
- BD Biosciences
- Reason for recall
- When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
- Action taken
- The firm has issued a customer Important Product Information letter via mail on 04/20/2007 to inform them of the software issues. The letter states that to avoid this problem, make sure each tube or well has at least two fluorescence parameters before exporting FCS 3.0 data files. Manually exporting tubes or wells one at a time or restarting the software after the export of an FCS data file containing one or no fluorescence parameters will prevent the problem from occurring. Customers are requested to fill out and return the response form and to contact BD Customer Support Center if there are any additional questions. A software fix is being developed in version 6.0 and a free maintenance release with no product enhancments (version 5.0.3).
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 1074 units
- Distribution
- Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and count
- Date initiated
- 2007-04-05
- Date posted
- 2008-08-16
- Date terminated
- 2009-09-30
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 (K062087) | Bd Biosciences | 2006-09-14 |