Recall Z-1702-2011 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.
| Date | Mar 17, 2011 (initiated Mar 27, 2009) |
| Status | Terminated |
| Reason | FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. |
| Root cause | Component design/selection |
| Action | Abbott Laboratories sent Product Correction letters, dated March 22, 2010, to its customers. The letter listed the additional products that are now included in the recall and gave an explanation of the reason for recall. The letter also discussed the safety impact and provided a list of necessary actions for customers. Customers are to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3000 Analyzer. If the fuse is correct, then the steps provided should be followed. If the fuse is incorrect, then customers are to |
| Quantity | 2219 units |
| Distribution | Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972354 | ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories, Sep 16, 1997 |