SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Brand(s)
Last updated
Summary
Product
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Issue
Medical devices - Performance
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. 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
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