—#84993

Product

CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA

FDA product code: gkz
510(k) numbers: K870233
Affected lot / code info: Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-06-08
Posted by FDA: 2010-05-20
Terminated: 2010-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.