15
Apr
2009

Cl Il CELL-Dyn Ruby Hematology Analyzer

0

Company:Abbott Laboratories.
Date of Enforcement Report 4/15/2009
Class:ll

PRODUCT
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes, Recall # Z-1064-2009

REASON
Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara , CA , by letter on November 17, 2008. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
604 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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