CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
FDA Recall Z-1629-2010 · Posted 2010-05-20
Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product Codegkz
Date Initiated2009-06-08
Date Terminated2010-12-03
Product Quantity11 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.