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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Abbott Laboratories is recalling CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical due to Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026