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Health Canada Medical devices

ORTHO OPTIX READER

Issued December 2, 2021
Issue
Ortho-clinical diagnostics confirmed that when the ORTHO OPTIX Reader software is determining the card lot number from the MTS card barcode, the software does not decode the appropriate numbers of the barcode. Recall start date: 2021-11-19
Hazard description
Software defect
Product
Product name
ORTHO OPTIX READER
Reference
ID
RA-63676