—#88541

Product

CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K961439
Affected lot / code info: List Number 07H95-01, manufactured between June 18 to November 11, 2009.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-12-29
Posted by FDA: 2011-03-11
Terminated: 2011-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88541. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.