Recall Z-2350-2010 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
| Date | Sep 2, 2010 (initiated Apr 16, 2010) |
| Status | Terminated |
| Reason | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. |
| Root cause | Nonconforming Material/Component |
| Action | Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to |
| Quantity | 69 units total. |
| Distribution | Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972354 | ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories, Sep 16, 1997 |