22

Aug

2007

Cl II Abbott Laboratories

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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