CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA
FDA device recall Z-1628-2010 · posted 2010-05-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
- Action taken
- A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- gkz
- Quantity affected
- 274
- Distribution
- Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Hon
- Date initiated
- 2009-06-08
- Date posted
- 2010-05-20
- Date terminated
- 2010-12-03
- 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 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (K870233) | Abbott Diagnostics | 1987-03-17 |