Recall Z-1623-2011 ยท GKZ Counter, Differential Cell
Abbott Laboratories
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 au
| Date | Mar 11, 2011 (initiated Dec 29, 2009) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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 Reca |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics, Oct 18, 1996 |