Recall Z-1629-2010 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
| Date | May 20, 2010 (initiated Jun 8, 2009) |
| Status | Terminated |
| Reason | Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 11 units |
| Distribution | Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics, Mar 17, 1987 |