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CELL-DYN Ruby (2017-11-22)
- Starting date:
- November 22, 2017
- Posting date:
- November 30, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-65288
Affected products
CELL-DYN Ruby
Reason
Abbott has identified occurrences of incorrect display of standard deviation (SD) values for specific hematological parameters in quality control (QC) view, QC-QCID view, and QC-L-J. View displays when unit sets other than the USA unit are selected on the CELL-DYN Ruby Analyzer. The issue does not impact QC results or instrument flagging of out-of-range results. There is no biohazard, electrical, physical, or chemical hazard as a result of this issue.
Affected products
CELL-DYN Ruby
Lot or serial number
Serial numbers below 70594BG
Model or catalog number
- 08H67-01
- 08H67-03
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES