BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to sim
FDA device recall Z-1530-2008 · posted 2008-08-08 · Terminated
Recall details
- Recalling firm
- BD Biosciences
- Reason for recall
- Values might not update in statistics views after certain functions are performed in a worksheet.
- Action taken
- The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 74 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2007-12-21
- Date posted
- 2008-08-08
- Date terminated
- 2008-09-24
- 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 |
| BD FACSCANTO SYSTEM (K040725) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |