Company: Abbott Laboratories
Date of Enforcement Report:8/22/2007
Class:ll
PRODUCT
a) 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,
Recall # Z-1170-2007
b) 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, Recall # Z-1171-2007p>
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 parameter limit has been exceeded)
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on May 7 and May 16, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4197 units
DISTRIBUTION
Nationwide and Internationally
