CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H

FDA device recall Z-1623-2011 · posted 2011-03-11 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.

Action taken

The firm, Abbott Laboratories, sent an "Urgent Field Safety Notice Product Recall" letter dated December 28, 2009 to the Customers via Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to destroy any CELL-DYN 4000 Vent Head Spring Assemblies that they have on hand and have not installed; (No action is necessary for assemblies that are currently installed on the CELL-DYN 4000 Analyzer); complete and return the Customer Reply form (even if they do not have the product) via fax to 1-800-777-0051 or email: QAGCO@abbott.comProduce Recall; indicate the number of Vent Head Spring Assemblies destroyed. the number identified will be replaced with Vent Head Spring Assemblies that meet specifications, and to please keep this communication with their CELL-DYN 4000 System Operator's Manual. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S., please contact your local hematology customer support representative.

Root cause

Other

Status

Terminated

Product code

GKZ

Quantity affected

157 assemblies

Distribution

Worldwide distribution: USA including states of: CA, CO, FL, GA, KY, NC, NJ, NY, OR, VA, and WV; and countries including: Argentina, Australia, Canada, Germany and Japan.

Date initiated

2009-12-29

Date posted

2011-03-11

Date terminated

2011-03-11

Location

Santa Clara, CA

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