Cell-Dyn Ruby Hematology Analyzer Cl Il

Company: Abbott Laboratories
Date of Enforcement Report 6/3/2009
Class:ll

PRODUCT
Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes. Recall # Z-1398-2009

REASON
Burn Risk– when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit). If the customer touches the motor, burns may occur.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter dated February 12, 2009. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
324 instruments

DISTRIBUTION
Nationwide and countries of Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.