Recall Z-1170-2007
Abbott Laboratories · initiated May 16, 2007
Product
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
Codes / lots: All serial numbers.
Reason for recall
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)
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1170-2007
- Initiated
- May 16, 2007
- Posted by FDA
- August 18, 2007
- Terminated
- January 11, 2011
- Product code
- GKZ – Counter, Differential Cell
- 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, Malaysia, Mexico, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand…
- Recalling firm
- Abbott Laboratories, Santa Clara, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1171-2007 | Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and…Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin… | 05/16/2007Terminated |