CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
- Company
- Abbott Laboratories
- Recall Initiated
- June 8, 2009
- Posted
- May 20, 2010
- Terminated
- December 3, 2010
- Recall Number
- Z-1629-2010
- Quantity
- 11 units
- Firm Location
- Santa Clara, CA
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.
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 Venezuela.
Lot / Code Info
Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96
Root Cause
Nonconforming Material/Component
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.