Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system
FDA device recall Z-1529-2008 · posted 2008-08-08 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
- Action taken
- A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 141 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Date initiated
- 2007-08-20
- Date posted
- 2008-08-08
- Date terminated
- 2012-10-15
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |