Recall Z-2017-2011 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
| Date | Apr 29, 2011 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Root cause | Pending |
| Action | Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US. |
| Quantity | 174 total units, all varieties |
| Distribution | Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972354 | ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories, Sep 16, 1997 |