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Synchron systems cholesterol (chol) reagent
Official notice
19 Nov 2021
Last checked
19 Nov 2021
An official Health Canada notice concerns Synchron systems cholesterol (chol) reagent. 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 Published 2021-11-19.
What to do now
Contact the manufacturer if you require additional information
Recall number
63635
Official notice
2021-11-19
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Beckman Coulter Canada L.p, Synchron Cholesterol Reagent.
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Recall details
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Documents, notices & source
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