Health product recall

Piccolo Xpress System - Comprehensive Metabolic Panel (2019-01-30)

Starting date:
January 30, 2019
Posting date:
June 7, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70117



Last updated: 2019-06-07

Affected Products

Piccolo Xpress System - Comprehensive Metabolic Panel

Reason

Abaxis is conducting a recall for specific lot numbers of the Piccolo Comprehensive Metabolic Panel Disks. Complaints were received from a small subset of customers experiencing values for the sodium assay running on average approximately 5 mmol/L higher than their reference method.

Affected products

Piccolo Xpress System - Comprehensive Metabolic Panel

Lot or serial number

8294AB4

8313AC1

8314AC1

8323AC0

8443AC1

Model or catalog number

400-0028

Companies
Manufacturer

Abaxis Inc.

3240 Whipple Road

Union City

94587

California

UNITED STATES