Health product recall

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

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

SYNCHRON Systems ISE Electrolyte Reference

Lot or serial number

M909206

Model or catalog number

A28937

Companies
Manufacturer

Beckman Coulter Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES