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Terminated

CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA

FDA Recall Z-1628-2010 · Posted 2010-05-20

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product Codegkz
Date Initiated2009-06-08
Date Terminated2010-12-03
Product Quantity274

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.

K870233CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZERAbbott Diagnostics · 1987-03-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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