Recall Z-1698-2011 ยท GKZ Counter, Differential Cell
Abbott Laboratories
The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories to human waste container systems
| Date | Mar 17, 2011 (initiated Nov 30, 2009) |
| Status | Terminated |
| Reason | The use of the device assemblies has been extended to a 6 month useful life. |
| Root cause | Other |
| Action | The firm, Abbott Laboratories, sent a "Product Correction" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or emai |
| Quantity | 874 |
| Distribution | Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030513 | CELL-DYN 1800 SYSTEM Abbott Laboratories, May 12, 2003 |
| K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics, Mar 17, 1987 |
| K951496 | CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER Abbott Laboratories, Oct 19, 1995 |
| K972354 | ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories, Sep 16, 1997 |
| K980614 | ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS Abbott Laboratories, Apr 24, 1998 |
| K991142 | CELL-DYN 1200 SYSTEM Abbott Laboratories, Jun 23, 1999 |