Recall Z-0706-2007 ยท GIF Diluent, Blood Cell
Abbott Laboratories
CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
| Date | Apr 3, 2007 (initiated Sep 29, 2004) |
| Status | Terminated |
| Reason | Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range |
| Root cause | Other |
| Action | On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed. |
| Quantity | 27,411 units |
| Distribution | Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972354 | ABBOTT CELL-DYN 3200 SYSTEM Abbott Laboratories, Sep 16, 1997 |