Z-1171-2007

Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled...

Name: Z-1171-2007 Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled...
Creator: Abbott Laboratories
Published: 2007-05-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-05-16 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN... on 2007-05-16. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1171-2007
Status: Terminated
Initiated: 2007-05-16
Posted: 2007-08-18
Terminated: 2011-01-11
Recalling firm: Abbott Medical
Product: Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, 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
Product code: GKZ Counter, Differential Cell
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)
Root cause tag: software
FDA 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 in commerce: 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, Uruguay, and Venezuela.
Product codes and lots: ALL serial numbers.

Product code GKZ

K870233Class IICell-Dyn 1600 Multiparameter Auto. Hema. AnalyzerAbbott Diagnostics / cleared 1987-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)