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Health Canada Medical devices

SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT

Issued November 19, 2021
Issue
Beckman coulter has identified that Synchron Systems Cholesterol Reagent lot M106450 may fail with out of calibration range low (OCR low) and/or back to back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. The continued use of Synchron Systems cholesterol reagent lot M106450 may lead to: -Further failed QC and/or calibrations -Erroneous low Cholesterol patient results Recall start date: 2021-11-08
Hazard description
Performance
Product
Product name
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Reference
ID
RA-63635