CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software allows you to ac
FDA device recall Z-1845-2011 · posted 2011-03-30 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
- Action taken
- Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that "as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality." The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 4552
- Distribution
- Worldwide Distribution
- Date initiated
- 2007-09-07
- Date posted
- 2011-03-30
- Date terminated
- 2011-03-31
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP (K946055) | Becton Dickinson Immunocytometry Systems | 1996-02-20 |