SYNCHRON Systems ISE Electrolyte Reference (2020-01-22)

Starting date:

January 22, 2020

Posting date:

February 28, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72419

Last updated: 2020-03-06

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  Reason
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  Affected products

Affected Products

SYNCHRON Systems ISE Electrolyte Reference

Reason

Beckman Coulter has identified that ISE Electrolyte Reference reagent lot M909206 may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results.

Affected products