Health product recall

SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT

Last updated

Summary

Product
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information

Affected products

Affected Products Lot or serial number Model or catalog number
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT M106450 467825

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

BECKMAN COULTER CANADA L.P.

7075 FINANCIAL DRIVE, MISSISSAUGA

ON, CANADA

L5N 6V8

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63635