Abbott CELL-DYN 3500 Hematology Analyzer
FDA device recall Z-1199-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The product failed electrostatic discharge testing, which could result in product failure.
- Action taken
- Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 3,429 units, all models
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kon
- Date initiated
- 2007-05-11
- Date posted
- 2007-08-29
- Date terminated
- 2008-06-19
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (K991605) | Abbott Laboratories | 1999-07-09 |
| ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS (K980614) | Abbott Laboratories | 1998-04-24 |
| CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) (K955715) | Abbott Laboratories | 1996-10-08 |
| ABBOTT CELL-DYN 3500R SYSTEM (K960427) | Sequoia Turner Corp. | 1996-05-02 |
| CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305) | Unipath , Ltd. | 1991-11-22 |