Recall Z-1170-2007 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Abbott Laboratories Diagnostics Division
| Date | Aug 18, 2007 (initiated May 16, 2007) |
| Status | Terminated |
| Reason | Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded) |
| Root cause | Other |
| Action | The firm initially sent reports (Product Information Letters) of this issue to the field on May 7, 2007. The firm sent a notice with customer notification response form on May 16, 2007 (Product Correction Letter). In addition, product information letters are being packed with the instruments accessory kit and quality control products used with the Cell-Dyn 1700 system. |
| Quantity | 4,197 units total (both models) |
| Distribution | WORLDWIDE: Product was distributed nationwide to all 50 states, as well as worldwide to Anguilla, Argentina, Australia, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Malay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER Abbott Diagnostics, Mar 17, 1987 |