CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic
FDA device recall Z-1170-2007 · posted 2007-08-18 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- 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)
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 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, Domi
- Date initiated
- 2007-05-16
- Date posted
- 2007-08-18
- Date terminated
- 2011-01-11
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (K870233) | Abbott Diagnostics | 1987-03-17 |